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1. er Shoulder Posterior Left Mar 07 2002 15 33 j Test analysis Shoulder Anterior w o Right Mar 07 2002 15 30 Fi initial x intercept 0 02 Shoulder Anterior w o Right Mar 07 2002 15 29 Test ster anence woes initial slope 3 73 Shoulder Anterior w ex Right Mar 07 2002 15 26 ex one 1528 angulation at 1 1378 21 00 m Shoulder Anterior w ex Right Mar 07 2002 15 24 i TIC re 1 Com Ligament Annotations Readings Cooborating Diagnosis Data xii initi es 3 pp 1 14 12 13 14 18 16 ang Edit ai fina Force dN Disp mm Angle deg a 1 a Cap Disp mm Enabled z _ Date Show m 0 00317 0 0 0025 0 0317 r The o2 05 o7 0 0 0566 073 3 Per a om 24 o 0173 24 3 EU 4 0466 483 0 034 483 3 5 062 61 D 0418 51 3 6 077 828 0 0544 829 73 7 092 104 0 0 655 104 3 8 109 D 0587 11 3 g t24 127 0 0774 127 K gt The raw test data for a specific patient can also be accessed by exporting these data as an Excel spreadsheet From the File menu select the Export function This will put the patient data including all test data in an Excel spreadsheet Once the data is in this format it can be manipulated by Excel or by any other program that can read an Excel file LigMaster User s Manual Sport Tech Inc Page 14 3 Using the patient database Once you are familiar with the basic operation of LIGMASTER it is
2. Partial tear caps ligs Figure C 23 Complete tear in caps ligs Slack in caps ligs Page 80 LSS E Potiert Test ew Took Hep m Talar Tit degrees Lateral Ankle Ligs 5 i 7 98 9S am H Fe Normal ATF p Diagrammatic examples of and CF J Pd LigMaster diagnostics display for Lateral ankle ligament injury z ra Pal Partial tear ATF Po Pi Pd CF intact 6 Fi a Figure C 25 Grade injury s gr a 3096 reduction in slope indicates 1 ni Pa 60 tear of ATF ve a 01 02 403 04 OS os 0 08 09 1 11 12 13 14 15 18 Ligamert Strain a 1 c 2 8 xl E Talar Tit degrees 1 2 3 1 5 T 8 8 10 7 2 3 M Normal ATF and CF E i 95 d E P d Figure C 26 Grade ll injury 5 wen 50 reduction in slope indicates E Pd p qe completely complete tear of ATF CF intact J ra ruptured Mi Q ut CF intact 34 Ld oi 202 o3 oa OS os Of DB 09 1 11i 12 13 14 15 18 Ligamert Strain a 1 M Normal ATF Pd ATF completely me and CF 4A ruptured CF partially Figure C 27 Grade lll injury z a torn 80 reduction in slope E a indicates complete tear of Ko 0 0 05 5 5 qut i ATF 60 tear of CF J i md 01 202 203 da OS 08 Qr 1 11 12 13 44 15 18 oe aa Ligamert Strain a i c LigMaster User s Manual Sport Tech Inc Page 81 Lateral Ankle Ligs cont Normal ATF Diagrammatic examples of and CF ATF and CF LigMaster diagnostics dis
3. Commonwealth of Virginia and the Federal Arbitration Act and shall benefit Sport Tech its successors and assigns Any claim or dispute between you and Sport Tech or against any agent employee successor or assign of Sport Tech related to this Agreement or the Software shall be resolved by binding arbitration in Charlottesville VA by and under the rules of the American Arbitration Association Any award of the arbitrator s may be entered as a judgment in any court of competent jurisdiction The United Nations Convention on Contract for the International Sale of Goods shall not apply to this Agreement Copyright 2002 2003 Sport Tech Inc All rights reserved LigMaster User s Manual Sport Tech Inc Page 2 SPORT TECH LIMITED WARRANTY STATEMENT 1 Sport Tech warrants to you the end user customer that Sport Tech hardware accessories and supplies will be free from defects in materials and workmanship after the date of purchase for a period of one year If Sport Tech receives notice of such defects during the warranty period Sport Tech will at its option either repair or replace products that prove to be defective 2 Sport Tech warrants to you that Sport Tech software will not fail to execute its programming instructions after the date of purchase for the period specified above due to defects in material and workmanship when properly installed and used If Sport Tech receives notice of such defects during the warranty period S
4. How the test WOIKS b t tbt eoe tr e iets ee E eb ur e Eee Eo E 38 AAO BlbOW M GL iiit e e E eiut e ee ta P e ettet etas rie oen 39 4 10 1 Setting up the stress device sssssssssssssssssseseseenene ennt nnne nnn nnns tenens 39 4 10 2 Posrioning TNE panem 3 intor rt ep ee hi ek eL E E Rag e E Ee RAS ESERE 40 4 10 3 Entering positioning information in the LIGMASTER software sssssseeee 41 4 10 4 Acquiring Joint Force response data sssesssesseeneenene ene 42 LigMaster User s Manual Sport Tech Inc Page 4 oo 00ON 4 10 5 Interpreting the diagnostic data ssseseeeneneneenenmeenen nennen 42 4 10 6 How the test Works ninsoarea sanear a E fite trie tra cn le npa iilum era tete Bre dne ee ements ENARA 42 4 11 Shoulder Anterior without external rotation sesssssseeseneeeeeneeee nennen 43 4 11 1 Setting up the stress device ssssssssssssssssssseeeeee enne nennen intrent 43 4 11 2 Positioning the patient eene tnnn enne nnne trn enne nn nns 44 4 11 3 Entering positioning information in the LIGMASTER software ssssseeee 44 Acquiring Joint Force response data sesssssssssseseseeeeeneeeneneen enne ener nennen enne 45 4 11 5 Interpreting the diagnostic data seessseseneeeneennenen nennen 45 ATTO How the test WOIKS cii p terrere nette e ret
5. Page 29 4 8 Knee MCL The medial collateral ligament of the knee can be readily examined by LIGMASTER With experience you will be able to take a full set of diagnostic data for the MCL in less than ten minutes 4 8 1 Setting up the stress device Before positioning the patient for a MCL test set up the stress device as shown below For most patients the side arms can be positioned in their extreme locations where A 20 and C 420 The pressure plate should be positioned with at B 190 and its center at the level of the knee joint space D Figure 4 8 1 Stress device settings for Knee MCL exam f Small patients or patients with short legs may require that the side arms are brought in closer to the pressure plate However the midpoint of the pressure plate with B at 190 should remain centered on the joint space and equidistant between the side arms If the test is based on a previous comparison the previous LIGMASTER settings will be recalled and can be used as a starting point for positioning the patient LigMaster User s Manual Sport Tech Inc Page 30 4 8 2 Positioning the patient The patient is requested to sit up on the examination table with the legs slightly spread apart and supporting him herself on outstretched arms behind his her back the beach position as shown in the illustration The stress device is then placed with the counterbearings on the medial aspect of th
6. fo IV Check when position set Set position B to fi 67 IV Check when position set Set position C to i20 IV Check when position set lt Back Cancel LigMaster User s Manual Sport Tech Inc Page 25 4 6 4 Acquiring Joint Force response data Once you have entered and verified the patient positioning data you are ready to apply force to the joint and to collect data on the resulting joint response See section 4 4 on acquiring test data 4 6 5 Interpreting the diagnostic data The force strain data collected on screen in real time provide the key to the diagnostic interpretation of the test results see How does LIGMASTER work in section 10 3 The first part of the graph up to about 6 dN force represents the visco elastic compression of the soft tissues of the calf muscles Above that force stretching of the ACL kicks in resulting in a sharp increase in the slope of the line If the ACL is partly torn the slope increases less dramatically in fact proportional to the extent of ACL tear When the ACL is completely torn the force strain relationship for the ACL breaks down entirely Continuing to increase the applied force will only further compress the soft tissues but eventually contributions from other knee structures such as collateral ligaments skin etc will cause the line to turn upward again The diagnostic part of LIGMASTER s software calculates the percentage ACL tear from the reduction in
7. to 342 v Check when position set Set position C to 420 v Check when position set lt Back Cancel 4 12 4 Acquiring Joint Force response data Once you have entered and verified the patient positioning data you are ready to apply force to the joint and to collect data on the resulting joint response See section 4 4 on acquiring test data Note that the maximum force for the shoulder ligament test should be no more than 12 dN 4 12 5 Interpreting the diagnostic data The extent of injury to the capsule ligaments of the gleno humeral joint specifically the inferior gleno humeral ligament is assessed in the same way as described for anterior shoulder without external rotation See under 4 11 5 4 12 6 How the test works The shoulder test with external rotation works in a fashion identical to the shoulder test without external rotation as described under 4 11 6 LigMaster User s Manual Sport Tech Inc Page 49 4 13 Shoulder Posterior The posterior components of the capsule ligaments of the gleno humeral joint can be readily examined by LIGMASTER With experience you will be able to take a full set of diagnostic data for the shoulder in less than ten minutes 4 13 1 Setting up the stress device Before positioning the patient for a posterior shoulder laxity test set up the stress device as shown below for the right shoulder The setup is similar to that of the anterior shoulder except that the 80mm extension pi
8. ATA Settngiuphe stress device tii e e e Re e tb bet ad 27 4 7 2 Posrmioning ING PATON cce tt hte bg eee eee eter to ee i re ates oet Ee cf 28 4 7 8 Entering positioning information in the LIGMASTER software 28 Acquiring Joint Force response data etaan k Ee E EREE RE AEN eaa REN ener nennen 29 4 7 5 interpreting the diagnostic data ccccceecccceeeecccceeeeeeceeeeeeeceeeeseeeeeesseeeeessseceeeenseeeeeeeeeaeentees 29 ZAMBIE O E E A E EE E EAE EE E 30 4 8 1 Setting up the Stress device sissien inan etiatn eds n e o ect ed eiecti tad 30 4 8 2 Pastonin TMG PALO Mt etri tere veo eee tester o ee i te rd Festes Poe Estoy 31 4 8 8 Entering positioning information in the LIGMASTER software 31 4 8 4 Acquiring Joint Force response data ssssssssesseeeneenene ener 32 48 5 HOW the test works best e e ese ei eerie t e oe enhance 33 AiO Knee EGL eque pre t A E ba er d dete e ptt e edes ri aet tod 34 4 9 1 Setting up the stress device sssssssssssssssssseseseenee eene nnne entren enn nnne tenens 34 4 9 2 Positioning TNE paheni ie rrt eie ek ub p e E de E Debe Ee Rs tud 35 4 9 8 Entering positioning information in the LIGMASTER software s es 35 4 9 4 Acquiring Joint Force response data sssesssssessseeeeeeeneneeen eene 36 4 9 5 Interpreting the diagnostic data cccceccccceeeecccceeeeeeceeeeeeeceeeeseeeeesseeaeeeeseeeeeeeseeeeeeseeeaeeneees 36 4 9 6
9. a way that is unrelated to that of the twin lateral ligaments The reduction in the value for the initial slope relative to that for the comparison uninjured deltoid is directly proportional to the percentage ligament tear For a complete tear the line no longer goes through the origin and is moved well to the right in the plot Slack shows as an intersection of the line with the x axis and can be assessed from the point of intersection but considerable slack approximately 4mm or more may be difficult to distinguish from complete tear 4 15 6 How the test works By applying force to the lateral aspect of the distal tibia the tibiotalar joint space widens medially thereby stretching the deltoid ligament The joint space averages 71mm in adults and has been entered into the program as default value Any deviation from this average when compared with the opposite ankle or pre injury same ankle does not affect the diagnostic outcome of the exam but researchers may want to change this value for their specific purpose and can do so by going to the Acquire Advanced box LigMaster User s Manual Sport Tech Inc Page 60 4 16 LigMaster repeatability and accuracy As mentioned earlier positioning of the patient is an important part of the stress exam Lack of attention to positioning the patient correctly and consistently is a major source of error in diagnostic results Examiners are advised to pay attention to detail and gain experience
10. a unique and integrated biotechnology company Sport Tech s mission is to provide health care workers with the best means to diagnose and treat the patients and athletes entrusted to their care and to keep orthopedic surgeons and sports physicians on the cutting edge of orthopedic diagnostic technology LigMaster User s Manual Sport Tech Inc Page 7 2 Getting Started 2 1 Before you start To operate the LIGMASTER system the operator must supply a PC Computer with USB port CD drive and Windows 98 Windows 2000 or Windows XP operating system LIGMASTER was written for small size and fast operation to run on any laptop or desktop computer with a USB port and Windows 98 2000 XP LIGMASTER requires as little as 10Meg of free hard drive space and can run in 2Meg of memory Sport Tech recommends at least a 200Mhz processor for best performance LIGMASTER does not need an external power supply Many laptop computers can power the LIGMASTER system for several hours or longer on a single battery charge Safety Note During LigMaster patient testing the computer should be operated using battery power or with an AC power supply that is rated for medical use with UL 2601 certification See section 11 1 for additional information LIGMASTER includes a 6 foot USB cable for connecting your computer to the stress device While this length cable is well suited for the majority of installations some customers may wish to pro
11. and can be used as a starting point for positioning the patient Once you have entered these numbers you must check the box on the right to verify the numbers 4 13 4 Acquiring Joint Force response data Once you have entered and verified the patient positioning data you are ready to apply force to the joint and to collect data on the resulting joint response See section 4 4 on acquiring test data 4 13 5 Interpreting the diagnostic data The extent of injury to the capsule ligaments of the gleno humeral joint can be assessed by comparison with the data from the opposite normal joint or pre injury same joint The force strain relationship shows an initial linear part representing compression of the soft tissues overlying the anterior aspect of the upper arm The linearity continues when the capsule ligaments of the shoulder joint kick in at higher force showing a steeper slope that is reduced proportional to the percentage capsular ligament tear relative to the comparison uninjured joint For complete tears the point of angulation between the two lines is well moved to the right on the screen Slack in the capsule ligaments can be quantified from the point of intersection of the second parts of the slopes with the x axis but considerable slack may be difficult to distinguish from complete tears Unlike ankle knee and elbow ligament injury shoulder capsule ligament tears have not been extensively examined by instrumented arthrometry As a
12. arm closest to the patient and that of the pressure plate hit Next The position for the side arm holding the wrist holding device appears automatically in the third box Acquire Test Data x Readings Set position C to the following ruler reading Reading A mm 20 Reading B rm fi 70 Set position C to 410 Check when position set If the test is based on a previous comparison the previous LIGMASTER settings will be recalled and can be used as a starting point for positioning the patient Once you have entered these numbers you must check the box on the right to verify the numbers LigMaster User s Manual Sport Tech Inc Page 41 4 10 4 Acquiring Joint Force response data Once you have entered and verified the patient positioning data you are ready to apply force to the joint and to collect data on the resulting joint response See section 4 4 on acquiring test data Note that the maximum force for the MUCL test should be no more than 12 dN 4 10 5 Interpreting the diagnostic data The extent of injury to the MUCL can be assessed by comparison with the data from the opposite normal MUCL or pre injury same MUCL The force strain relationship shows an initial linear part representing compression of the soft tissues overlying the lateral aspect of the elbow joint before the MUCL kicks in at approximately 6dN force The linearity continues from thereon at a steeper slope that is reduced pro
13. average 71mm When comparing with the opposite or same ankle any deviation from this default average will not affect the diagnostic outcome but researchers may want to adjust this value for their specific purpose The Acquire Advanced box permits the examiner to do so The talar tilt angle as shown on the upper x axis of your screen is calculated by LIGMASTER V s software from the linear and rotary displacements recorded by encoders using trigonometric considerations applicable to ankle inversion However because of patient to patient variability patient specific parameters required for the calculation of the talar tilt angles are not entered for practical reasons As a result the values for the talar tilt angles recorded on the upper x axis are larger than those expected from X ray examinations Research by Sport Tech s clinical staff has shown that talar tilt angles by LIGMASTER M exceed those by X rays by a factor of about 2 5 This discrepancy is not a problem for making the correct diagnosis when the obligatory comparison with the pre injury same or opposite normal ankle is routinely made See also under 5 Diagnostic aids In addition to the talar tilt angles subtalar tilt angles can be calculated from the same stress study and are recorded and reported in the diagnostic dialog box However no clinical validation of abnormal subtalar angles recorded by LIGMASTER is at the time of writing this manual available to verify the clini
14. below for the right MUCL One side arm holding a counterbearing is placed close to the edge of the table the other side arm accommodates the wrist holding device Wa Figure 4 10 1 Stress device settings for right MUCL exam a Hh For the right MUCL set A at 20 and B in a location where the midpoint of the pressure plate is centered on the elbow joint space The elbow should be flexed 15 degrees to unlock the olecranon from its bony socket in the trochlea When you enter the positions of A 20 and that of B in the positioning information boxes the correct position for C will be automatically calculated by the software The wrist is secured in extreme supination by inserting another counterbearing into the wrist device so as to accommodate the grip of fingers and thumb The two support rods are then inserted just under and just above the wrist to fixate the wrist in the correct position See illustration For the left MUCL set C at 420 and proceed with B and A as described above If the test is based on a previous comparison the previous LIGMASTER settings will be recalled and can be used as a starting point for positioning the patient LigMaster User s Manual Sport Tech Inc Page 39 4 10 2 Positioning the patient The patient is requested to sit up on an adjustable height stool next to the examination table on which the stress device is placed with the side arm closest to the patient flush wit
15. desktops For use on the playing field or locker room you may wish to consider an industrial laptop which is built to operate in harsh environments and to withstand falls These are available from a number of specialized manufacturers and tend to be more expensive than a standard laptop USB is a low power interface and very safe To reduce the possibility that an unusual event such as lightning strike or power surge could cause a potential shock hazard it is best to operate LIGMASTER M using battery power whenever possible When battery power is not available the computer should use a power supply or isolation transformer which is rated for medical use with a UL 2601 certification Makers of medical rated power supplies and isolation transformers include Duramicro OperatingTech TRUMPower Absopulse and Tripp Lite 11 2 How do l integrate the LIGMASTER PC into the office network LIGMASTER is capable of exporting patient files as Excel spreadsheets which can be manipulated by other programs The simplest and cheapest way to share these files with other computers is to copy the files onto a floppy disk or some other removable media If you transfer files often you may want to consider using Ethernet or some other local network to connect your LIGMASTER computer with other office computers If you have a modem connection on your computer you can email patient files to other computers this can be useful if you want to share data
16. into the computer s USB jack When taking test measurements on a patient the USB cable should be attached before starting the LIGMASTER M software In the figure below the stress device is configured to test the right lateral ankle ligaments Figure 2 3 rotary encoder cable LigMaster system E e e Computer with E N LigMaster TM Stress f Device USB cable For examining ankle ligaments an additional RJ45 cable attachment is required to connect the pressure actuator faceplate with the bottom of the stress device arm to which the rotary ankle holder is attached Note that when the rotary ankle holder is moved to the other side of the stress device the cable must be moved also The cable is bi directional so it does not matter which end is plugged into the pressure actuator faceplate Once the positions of the side arms and the pressure actuator have been chosen for your specific exam and befitting the patient s anatomy the locking mechanisms should be engaged to secure the components of the stress device LigMaster User s Manual Sport Tech Inc Page 10 2 4 Getting familiar with the LIGMASTER software The first time that the LIGMASTER software is launched it will display diagnostic information for a fictional patient Test data is available for ligaments of the ankle knee elbow and shoulder with examples of both normal and injured ligaments You can use this patient data to familiarize yourse
17. is positioned on his her same side as the knee to be examined The counterbearings are placed on the posterior aspects of upper leg and lower leg and the pressure plate positioned just distal to the tibial tuberosity as illustrated Otherwise all considerations are as under 4 6 2 Figure 4 7 2 Right Knee mounted in stress device for PCL exam 4 7 8 Entering positioning information in the LIGMASTER software Once you have positioned the patient in the stress device you must enter the positions for each side arm usually with A at 20 and C at 420 and of the pressure plate If the test is based on a previous comparison the previous LIGMASTER settings will be recalled and can be used as a starting point for positioning the patient Once you have entered these numbers you must check the box on the right to verify the numbers LigMaster User s Manual Sport Tech Inc Page 28 Acquire Test Data i x Readings Set device positions to the following ruler readings Set position A to 20 v Check when position set Set position B to f 67 I Check when position set Set position C to 420 v Check when position set lt Back Cancel 4 7 4 Acquiring Joint Force response data Once you have entered and verified the patient positioning data you are ready to apply force to the joint and to collect data on the resulting joint response See section 4 4 on acquiring test data 4 7 5 Interpreting the diagn
18. it may be necessary to move the distal side arm closer in The pressure actuator should be positioned on the slide bar with the center of the pressure plate just proximal to the bulk of the calf muscles and distal to the attachment of the hamstring tendons on the tibia This position is patient dependent and should be recorded for each patient and reproduced on subsequent re examinations this is done automatically if you select a previous test as a reference Care should be taken that the patient relaxes his her leg muscles during the exam The knee should be in neutral LigMaster User s Manual Sport Tech Inc Page 24 position in the device and not rotated You can check on the correct position by observing the location of the hip joints which should remain straight above one another Figure 4 6 2 Left Knee mounted in stress device for ACL exam 4 6 3 Entering positioning information in the LIGMASTER software Once you have correctly positioned the patient in the stress device you must enter the positions for each side arm A and C and of the pressure plate B If the exam is based on a previous comparison the previous LIGMASTER settings will be recalled and can be used as a starting point for positioning the patient Once you have entered these numbers you must check the box on the right to verify the numbers Acquire Test Data x Readings Set device positions to the following ruler readings Set position A to
19. that G is proportional to the remaining functional fibers in the ligaments GST has been validated by graded stress radiography of ankle knee and elbow ligaments in over 1000 patients diagnosed treated and followed up LIGMASTER capitalizes on this wealth of clinical information by having incorporated GST in its software to present the diagnosis of ligament tear in percentage functional loss or recovery However LIGMASTER s main feature remains its capability to collect all required data from linear and angular displacements in the course of the stress exam and to eliminate the need for recording displacements by X ray documentation The stress exam has thereby become available to health careworkers at considerably decreased expense no radiation hazard to patients and at vastly reduced time effort References Treloar LRG The physics of rubber elasticity Oxford Clarendon 1967 Rijke AM Lateral Ankle Sprains The Physician and Sportsmedicine Vol 19 2 1991 Rijke AM Perrin DH Goitz HT McCue FC Instrumented Arthrometry for Diagnosing Partial Versus Complete Anterior Cruciate Ligament Tears AM J Sports Med Vol 22 2 1994 Rijke AM Goitz HT McCue FC Andrews JR Berr SS Stress Radiography of the Medial Elbow Ligaments Radiology Vol 199 1994 LigMaster User s Manual Sport Tech Inc Page 72 10 Appendix C Patterns of ligament injury ACL Normal ACL F Pd Diagrammatic examples of LigMaster diagnostic dis
20. the line for the injured ankle has been adjusted accordingly This feature has been added to the interpretation of the test data to allow for the clinically well known fact that there exists a large overlap in range between normal and that of abnormal injured talar tilt angles As a result the difference between the two rather than the absolute values of the normal and injured talar tilt angles are entered into the calculation of the percentage ligament tear Obviously if the comparison ankle was unstable at the time of the first examination its value as normal comparison will be much reduced Because the lateral ligaments consist of two separate ligaments with their lengths running in different directions the reduction in the slope of the line relative to that of the comparison is determined by contributions from both ligaments Almost always the ATF is the first ligament to rupture in an inversion trauma followed by tearing of the CF ligament only if the trauma involves a hyperdorsiflexion component As a result the first fifty percent reduction in the slope represents a partial grade l or at fifty percent a complete rupture of the ATF grade II whereas a further reduction would involve an additional partial tearing of the CF grade Ill This latter grade is however a rare LigMaster User s Manual Sport Tech Inc Page 55 occurrence clinically Much more common is a grade IV injury in which both ATF and CF are completely torn
21. the second part of the slope compared with that of the normal opposite ACL or pre injury same ACL Complete tears are identified by the delayed appearance in the upturn in the soft tissue compression part of the force strain relation ship Slack or redundancy in an ACL can be identified and quantified by noting the displacement in millimeters ligament extension required to take out the slack relative to the comparison ACL The second parts of the force strain lines will then run parallel intersecting the x axis at different points This difference equals the slack in mm The diagnostic dialog box summarizes the results in the left hand column LigMaster User s Manual Sport Tech Inc Page 26 4 7 Knee PCL A LIGMASTER exam of the PCL is very similar to that of the ACL but the acquired force strain relationship is somewhat different With experience you will be able to take a full set of diagnostic data for the PCL in less than ten minutes 4 7 1 Setting up the stress device Before positioning the patient for a PCL test set the stress device up as shown below If the test is based on a previous comparison the previous LIGMASTER settings will be recalled and can be used as a Starting point for positioning the patient s dH 9 Figure 4 7 1 Stress device settings for PCL exam Em LigMaster User s Manual Sport Tech Inc Page 27 4 7 2 Positioning the patient As with the ACL exam the patient
22. to accommodate the flexed elbow Smaller patients can be accommodated in the stress device by relocating the positions of the counterbearings closer to the slide bar and or using the plastic extension piece for the pressure plate If the test is based on a previous comparison the previous LIGMASTER settings will be recalled and can be used as a starting point for positioning the patient LigMaster User s Manual Sport Tech Inc Page 43 4 11 2 Positioning the patient The patient is requested to sit down on an adjustable height stool with the shoulder abducted 90 degrees and the elbow flexed 90 degrees The counterbearing closest to the patient mounted on the extension piece if necessary is brought level with the coracoid process The pressure plate is positioned at the upper posterior aspect of the proximal humerus and the other counterbearing at the anterior aspect of the distal humerus The lower arm is stabilized using the distal counterbearing as illustrated in Fig 4 11 2 Make sure that the patient is sitting upright chest out and touching but not leaning into the counterbearing Also make sure that the patient is not slumping with the shoulder falling away from the counterbearing The arm muscles should be relaxed Figure 4 11 2 Left Shoulder mounted in stress device for anterior exam with no rotation 4 11 3 Entering positioning information in the LIGMASTER software Once you have positioned the patient in the stress d
23. with other physicians 11 3 How Does LIGMASTER Work The joint to be tested is positioned in a stress device and a specifically directed force is applied The displacement of the joint components is read by incremental encoders and a digital or analog signal is generated An interface board reads the signal and causes conversion to a digital signal if necessary The interface board processes the force displacement signal and sends the information to a computer processor for analyzing the data computing the results and finally presenting the information in clinical format Rotary encoders are attached at each of the two positions on the stress device where the ankle piece can be inserted These encoders measure the rotation of the ankle LigMaster User s Manual Sport Tech Inc Page 84 piece A shaft on the bottom of the ankle holding piece slides into a hole on the Telos device the entire ankle holding piece can swivel on this shaft The rotary encoders are located at the base of this shaft so as to measure the rotation of the shaft A linear encoder is attached to the device in line with the pressure plate to measure the distance that the pressure plate travels while the force is being applied To test the ankle requires rotational measurements from the rotary encoder distance measurements from the linear encoder and measurements of the force applied by the pressure plate To examine knee elbow and shoulder ligaments only the d
24. 04 5 1 d d ie H FL ac d Right Shoulder Anterior wi extra 24 lt 4 we 14 ad 5 ow 171mm ee T T T T T T T T T T T T T T T 02 01 0 01 02 03 04 05 06 OF 08 09 1 11 142 313 Strain 1 0 Plot view Summary View LigMaster User s Manual Sport Tech Inc Page 11 2 4 2 Selecting Tests LIGMASTER M can display the results of a single test or it can display a test together with another set of data for comparison To display another test or a test and comparison open the Test Select dialog box from the Test menu amp ligMaster Doe John _ 3 ini xj Patient Test View Tools Help Capsular Displacement mm 6 Bu m fee db Patient name Doe John s Doe John Last seen Thu Mar 07 13 10 14 2002 Test Right Shoulder Anterior w ext rot LB Date Thu Mar 07 15 26 43 2002 Rotana Ir Or 202 15 J Comparison Right Shoulder Anterior w ext rot Date Thu Mar 07 15 24 37 2002 T eie LL s DE initial x intercept 0 01 y m initial slope 4 50 Tye Sie Date EPA Ape won angulation at 0 9672 16 93 r Shoulder Posterior Left Mar 07 2002 15 36 final slope 25 37 Shoulder Posterior Left Mar 07 2002 15 35 Shoulder Posterior Left Mar 07 2002 15 33 T Shoulder Anterior w o Right Mar 07 2002 15 30 Comparison analysis Shoulder Anterior w o Right Mar 07 2002 15 29 initial slope 4 70 Shoulder Anterior w ex angulation at 0 8911 15 23 r amp Shoulder Anterior w ex Right Mar 07 2002 15 24 final s
25. 1 02 Shoulder Anterior w o ext n The Test has more laxity Percentage Increased La Edit Delete Cancel LigMaster User s Manual Sport Tech Inc Page 16 4 Measuring Ligament function Once the relevant patient information has been entered into LIGMASTER M you are ready to test ligament function A note on test comparisons Whenever possible it is advantageous particularly for athletes to compile a complete inventory of ligament function before any injury is likely to occur i e at the beginning of the season This allows a comparison of the test data with those of the same intact pre injury ligaments If such prior data is not available a comparison with the normal ligaments of the opposite joint is generally adequate although not quite as accurate It is not unusual to see difference in ligament function of 10 20 percent on opposite joints particularly if there has been a history of previous injury 4 1 Selecting the test The first step is to select the test that you will perform on the patient This is done from the Test menu bar Selecting a New test will activate a series of dialog boxes which will take you through setting up a new test step by step The first dialog box lets you select the type of test Select the ligament s to be tested from the drop down menu Once you have selected the ligament select the right or left side FIUTETDTIm EE 2 inl x Patient Test View Tools Help i Capsular D
26. A at 20 and C at 420 Once you have entered these numbers you must check the box on the right to verify the numbers Acquire Test Data xj Readings Set position B to the following ruler reading Reading A mm 20 Set position B to fi 30 Check when position set Reading C mm 420 Cancel Once the A and C values have been entered and verified the B value will be automatically calculated for you 4 9 4 Acquiring Joint Force response data Once you have entered and verified the patient positioning data you are ready to apply force to the joint and to collect data on the resulting joint response See section 4 4 on acquiring test data 4 9 5 Interpreting the diagnostic data LigMaster User s Manual Sport Tech Inc Page 36 The extent of damage to the LCL can be assessed by comparison of the test results with those of the normal opposite LCL or pre injury same LCL Because of the absence of bulky soft tissue on the medial aspect of the knee the force strain relationship is determined in the first place by the integrity of the LCL and only secondarily by the elastic compression of the soft tissues nearest the counterbearings and their rubber coverings The initial slope therefore represents the tensile properties of the LCL This slope is reduced for partial tears proportional to the percentage tear For complete tears the line no longer goes through the origin but is displaced t
27. In grade IV injuries the ruptured ligaments are no longer continuous and as a result the recorded force displacement relationship no longer represent their tensile properties a feature recognized and interpreted as such by the diagnostic software Slack in the lateral ligaments can be identified and quantified by noting the displacement in millimeters ligament extension required to take out this slack The force strain line will run parallel to the comparison line and intersect the x axis indicating the slack in mm See Appendix B for details For very large slack more than about 4mm distinction from complete tear can sometimes be difficult The patient s history may be helpful here Unlike knee elbow and shoulder injuries a history of ligament trauma to the contralateral ankle is quite common in patients who present with an ankle sprain Several studies have shown that as much as 30 percent of ankle patients have suffered an old injury to the opposite ankle If no normal opposite or pre injury same ankle is available for comparison the above described interpretation cannot be reliably applied In these cases Sport Tech recommends using the positive predictive value ppv of finding a particular grade of ligament injury based on the apparent talar tilt angle at 15daN by LigMaster as a source of information on the patient s ligament status To access the ppv ini xi N Patient Test View Too
28. Inc Page 66 7 LIGMASTER Support If you have a question or problem that you cannot resolve with this manual and troubleshooting guide check the www ligmaster com website Here you will find the most up to date information on using LIGMASTER M You can also address questions to Sport Tech s top technical and clinical staff or compare notes with other LIGMASTER users 8 LigMaster Research Research projects have never before enjoyed easy inexpensive access to the type of data produced by LIGMASTER The Acquire Advanced box provides the researcher with the option to change joint parameters that have been entered as default values for the purpose of clinical expediency only In addition patient data can be exported as an Excel spreadsheet This allows the raw data in tabulated form to be assessed by Microsoft Excel or any other program that supports the Excel format allowing for alternative data manipulation and processing Researchers are encouraged to consult the www ligmaster com website to stay abreast of new developments and ongoing research projects involving LIGMASTER recent publications on joint stability etc LigMaster User s Manual Sport Tech Inc Page 67 8 Appendix A Ligament Injury Diagnosis and Treatment Clinical Considerations Ligament damage constitutes an important part of traumatic and athletic injuries and is frequently associated with internal derangement of the joint Initial work up is aimed
29. LigMaster by Sport Tech Inc March 4 2003 Sport Tech License Agreement ATTENTION USE OF THE LIGMASTER SOFTWARE IS SUBJECT TO THE SPORT TECH LICENSE TERMS SET FORTH BELOW USING THE SOFTWARE INDICATES YOUR ACCEPTANCE OF THESE LICENSE TERMS IF YOU DO NOT ACCEPT THESE LICENSE TERMS YOU MUST RETURN THE SOFTWARE FOR A FULL REFUND IF THE SOFTWARE IS SUPPLIED WITH ANOTHER PRODUCT YOU MAY RETURN THE ENTIRE UNUSED PRODUCT FOR A FULL REFUND SPORT TECH SOFTWARE LICENSE TERMS The following License Terms govern your use of the accompanying Software unless you have a separate written agreement with Sport Tech License Grant Sport Tech grants you a license to use one copy of the LIGMASTER M Software hereinafter the Software on a single computer Use means storing loading installing executing or displaying the Software You may not modify the Software or disable any licensing or control features of the Software If you have purchased a site license you may use the software on the number of computers defined by and in accordance with the site license Ownership The Software is owned and copyrighted by Sport Tech Your license confers no title or ownership in the Software and is not a sale of any rights in the Software Copies You may make one 1 copy of the Software for backup purposes You must reproduce the copyright notice in the original Software on all copies or adaptations No other copying is permitted You may not
30. accurate and repeatable results As with most tools you will become more proficient with practice Generally an experienced physician or technician can get first time results that are accurate to within 10 percent Once you have performed the tests a few times you should see your accuracy improve to 2 5 percent When working with a new patient it is usually helpful to repeat the first test on the patient s comparison healthy joint so as to render him her familiar enough with the examination procedure to relax properly which aids in getting reproducible results before proceeding with the test joint LigMaster User s Manual Sport Tech Inc Page 20 4 5 Acquiring Stress data Once you have positioned the patient and entered the patient positioning data you are ready to begin the exam The dialog screen below is used for data acquisition Acquire Test Data x Acquire Data Acquire the data r Auto Acquire Options r Real Time Data Nulluntifforce exceeds dN 0 His 0 00 aN Displacement 0 0 mm Start when force exceeds dN o Angle IN Stop when force exceeds dN fis Null Displacement tees There are two methods that can be used to acquire patient data Manual and Auto Acquire Manual mode provides the most control over the data acquisition however the operator must perform a few extra steps Auto Acquire automates most of the steps according to settings that have been previously entered by the op
31. al Tear MUCL Figure C 13 Partial Tear in MUCL Normal MUCL Figure C 14 Complete Tear in MUCL 2d Complete Tear Pd MUCL tns et Slack in MUCL Figure C 15 Slack in MUCL Page 77 LigMaster User s Manual Sport Tech Inc Shoulder Anterior Without external rotation Diagrammatic examples of LigMaster diagnostics display for Shoulder anterior ligament injury Figure C 16 Partial tear in caps ligs Normal caps ligs Complete tear caps ligs Figure C 18 Slack in caps ligs LigMaster User s Manual Sport Tech Inc Normal caps ligs Partial tear caps ligs Figure C 17 Complete tear in caps ligs caps ligs Page 78 Shoulder Anterior With external rotation Diagrammatic examples of Normal LigMaster diagnostics display caps ligs for Shoulder anterior ligament injury d Partial tear caps ligs Figure C 19 Partial tear in caps ligs i F i Complete Figure C 20 Complete tear in caps ligs a tear caps ligs Normal caps ligs Slack in caps ligs Figure C 21 Slack in caps ligs Page 79 LigMaster User s Manual Sport Tech Inc Shoulder Posterior Diagrammatic examples of LigMaster diagnostics display for Shoulder posterior ligament injury Figure C 22 Partial tear in caps ligs Normal caps ligs Complete tear caps ligs Figure C 24 Slack in caps ligs LigMaster User s Manual Sport Tech Inc Normal caps ligs
32. at excluding osteochondral fractures dislocations and neuro vascular involvement followed by an assessment of ligament injury Information on the extent of ligament damage is important because in practice this determines the treatment of choice whether to treat conservatively or consider surgery In conservatively managed injuries the extent of initial ligament damage ultimately determines prognosis and time to recover The work up of ligament injury routinely involves a physical examination x rays and on occasion stress radiography MRI arthrography or arthroscopy Each of these diagnostic tools has its own intrinsic value and thus contributes to the total assessment of the ligament injury However it is evident that each examination also markedly adds to total cost The LIGMASTER procedure combines speed and non invasiveness with reliability and safety It has moreover a unique advantage over all other techniques in that it provides direct information on the extent of ligament damage in terms of percentage functional loss or recovery that is critical to the decision making process LIGMASTER has been designed to operate using ligament stress devices that have a long clinical history of safety and reliability As a result some of the limitations of these devices are shared by LIGMASTER Stress exams provide information on ligaments only and cannot exclude other injuries such as osteochondral fractures or meniscal tears that
33. by trying out new stress exams before patients are tested Studies performed by Sport Tech s own clinical staff have shown that test results in the hands of beginners are accurate to within 1096 but this improves to 4 596 after several trial runs Ultimately you should be able to perform a stress study within 296 accuracy Patent Test view Took Hep a Ime Extension mm The display to the right t1 7 1t 9 9 W v mpg 4o shows a good example of a d 144 repeated normal ACL al exam performed by an i experienced examiner 14 NT Note that the final slopes 14 and points of angulation of the two plots are nearly identical Consistent plots such as these require Force dN o o 1 1 careful attention to accurate a and consistent patient 34 positioning Pe ul Taa I 1 1 1 1 T 1 1 T 1 I 1 I 0 0 1 0 2 0 3 04 05 06 0 7 08 09 1 1 1 12 13 Ligament Strain 4 1 7 LigMaster Doe John lO xi Potent Tes view Took Heb rere Ligament Extension mm 2 4 8 1 12 4 16 18 20 22 2 26 2 The display to the left shows an example of the maximum acceptable variability that one would expect in a series of repeated tests about 5 percent variation of the final slope Note the difference in the point of angulation This measurement is very sensitive to patient positioning Force dN T 1 T T 1 T 0 01 02 03 04 05 06 07 08 09 1 11 12 13 14 Ligament Strain 1 22 LigMaster User s Manua
34. cal significance of these data LigMaster User s Manual Sport Tech Inc Page 57 4 15 Ankle Medial Deltoid Injury to the medial deltoid ligaments of the ankle is much less common than lateral injury However LIGMASTER enables you to examine this type of injury in a similar fashion With experience you will be able to take a full set of diagnostic data for the medial ankle ligaments in less than ten minutes 4 15 1 Setting up the stress device Before positioning the patient for a medial ligament ankle test set up the stress device as shown below If the test is based on a previous comparison the previous settings will be recalled and can be used as a starting point for positioning the patient Note Do not forget to connect the rotary encoder cable Figure 4 15 1 Stress device settings for left medial ankle exam LigMaster User s Manual Sport Tech Inc Page 58 4 15 2 Positioning the patient The patient is positioned as described under 4 14 2 but here the ankle is mounted in the ankle holder for eversion testing the pressure actuator is positioned on the lateral aspect of the distal fibula and the counterbearing is facing the medial aspect of the proximal tibia Figure 4 15 2 Right Ankle mounted in stress device for medial exam 4 15 3 Entering positioning information in the LIGMASTER software Once you have positioned the patient in the stress device you must enter the positions o
35. can be plugged into an available PC or laptop No external power source is necessary as the LIGMASTER electronics package is powered through the computer s USB port LIGMASTER M is covered by United States patents 6 419 645 5 724 991 and 5 462 068 1 3 LIGMASTER Advanced Diagnostics LIGMASTER is the first commercially available technology capable of providing a diagnosis of ligament injury or extent of recovery in terms of percentage tear Because patient treatment and outcome are to a large degree determined by the remaining ligament function this detailed information is important in helping health care professionals to decide on the treatment of choice including whether to perform surgery or treat conservatively LIGMASTER assesses the damage to the injured ligaments in functional terms rather than in morphological terms as do MRI arthroscopy and to an extent ultrasound This is a significant advantage because in ligament damage it has been well established that the prognosis of conservatively managed ligament injury is determined by the extent of functional loss at the time of trauma 1 4 About Sport Tech Since 1995 Sport Tech Inc has worked to develop novel products in the field of sports medicine through the diagnosis treatment monitoring and rehabilitation of sports injuries The company is blending sports medicine and the nation s interest in physical fitness with engineering and computer disciplines to become
36. ce a a aaie ada ra Se aa RR rea t et NR 2 ER AE EAD 66 6 1 Acquire data menu does not show force and displacement readings ssssse 66 The test curve abruptly turns into a vertical line ssssssssseeeeeneeenneene enn 66 6 3 The response curve for an ankle seems to be abnormally steep 66 6 4 A portion of the test curve turns into a vertical line 66 EiGMASTER TM SUPPO im aaeeea de aeter ir packet se Ra Dn eta eate X AER cater date pt xd aa daa 67 Be TETSISTBRC Ide AAE ARAE AA A ORAE NEES AEAT AE A ERAT E SAAT AEE AENA 67 Doleo qoe EE 68 TeS AE E ds EE 71 Appendix C Patterns of ligament injury essen nennen enne 73 Commonly asked questions cccceceeeeeeeneeeeeeeceeeeeeaaeeeseneecaeeecaaeeseaaeseaeeecaeeeseaeeseneeseeeeseaeeeeeteaes 84 11 1 What kind of computer should get ssssssssssssssesseeseeeenennneeen nennen nnne 84 11 2 X How do l integrate the LIGMASTER PC into the office network sssssssssse 84 11 3 How Does LIGMASTER Work sssssssssssssseseees ener enne nnne nn nene innen nnn sn nnne nennen 84 LigMaster User s Manual Sport Tech Inc Page 5 1 Introduction Welcome and congratulations on your investment in the LIGMASTER ligament diagnostic system 1 1 LIGMASTER Benefits With a simple non invasive examination LIGMASTER allows a trained technician to quickly determine the pe
37. ce exceeds dN o Angle MV Stop when force exceeds dN 15 Null Displacement L J lt Back Start Cancel LigMaster User s Manual Sport Tech Inc Page 23 4 6 Knee ACL The ACL is one of the most commonly injured ligaments With experience you will be able to take a full set of diagnostic data for the ACL in less than ten minutes 4 6 1 Setting up the stress device Before positioning the patient for ACL testing set the stress device up as shown below Move the counterbearings in closer for smaller legs or mount the plastic extension piece onto the pressure plate If the test is based on a previous comparison the previous LIGMASTER settings will be recalled and should be used as a starting point for positioning the patient Figure 4 6 1 h Stress device settings for ACL exam paat to 4 6 2 Positioning the patient The patient is placed on his her same side as the knee to be tested The opposite leg is flexed at the hip and knee as illustrated A pillow under the opposite knee will make the patient more comfortable The sliding side arms of the stress device are placed in their extreme positions where A reads 20 and C reads 420 The leg under examination is positioned so that the proximal counterbearing is located with its center 5 cm above the patella and the distal counterbearing anywhere on the anterior aspect of the tibia above the ankle joint For short legs
38. comparison the previous LIGMASTER settings will be recalled and can be used as a starting point for positioning the patient LigMaster User s Manual Sport Tech Inc Page 34 4 9 2 Positioning the patient The patient is requested to sit up on the examination table with the legs slightly spread apart and supporting him herself on outstretched arms behind his her back the beach position as shown in the illustration The stress device is then placed with the counterbearings on the lateral aspect of the leg and the midpoint of the pressure plate centered on the medial aspect of the knee joint space AES Figure 4 9 2 Left Knee mounted in stress device for LCL exam 4 9 3 Entering positioning information in the LIGMASTER software Once you have positioned the patient in the stress device you must enter the positions for each side arm If the test is based on a previous comparison the previous LIGMASTER settings will be recalled and can be used as a starting point for positioning the patient LigMaster User s Manual Sport Tech Inc Page 35 Acquire Test Data 1 x Readings Position the patient and record the ruler readings A and C Reading A mm 20 IV Check when value entered Reading C mm 420 zan Because the pressure head must be located equidistant between the two counterbearings LIGMASTER will ask you to first enter the two counterbearing locations usually with
39. deviation from this average when compared with the opposite or same joint will not affect the diagnostic outcome of the exam but researchers may want to adjust this value for their specific purpose The Acquire Advanced box permits the examiner to do so LigMaster User s Manual Sport Tech Inc Page 42 4 11 Shoulder Anterior without external rotation The capsular ligament laxity of the gleno humeral joint of the shoulder can be readily examined by LIGMASTER M With experience you will be able to take a full set of diagnostic data for the shoulder in less than ten minutes 4 11 1 Setting up the stress device Before positioning the patient for a shoulder laxity test set up the stress device as shown below for the left shoulder The side arm closest to the patient with A 20 for the right shoulder C 420 for the left shoulder is positioned along the edge of the exam table and equipped with a counterbearing For larger patients it may be necessary to add the 80mm extension piece extending outwards so that the counterbearing can be brought level with the patient s coracoid process e Figure 4 11 1 V Stress device settings for left anterior shoulder exam with 80mm extension 2 C Dus ia a i The pressure actuator is positioned so as to touch the proximal aspect of the patient s upper arm The other side arm equipped with a counterbearing is positioned at the level of the distal humerus so as
40. distribute copies of the Software or accompanying documentation to others Transfer You may transfer the Software to another person provided that you notify Sport Tech of the transfer Your license will automatically terminate upon any transfer of the Software Upon transfer you must deliver the Software including any copies and related documentation to the transferee The transferee must accept these License Terms as a condition to the transfer Termination Sport Tech may terminate your license upon notice for failure to comply with any of these License Terms Upon termination you must immediately destroy the Software together with all copies adaptations and merged portions in any form Export Requirements You may not export or re export the Software or documentation except in compliance with the laws and regulations of the United States U S Government Restricted Rights The Software and documentation are provided with Restricted Rights They are delivered and licensed as commercial computer software as defined in DFARS 252 227 7013 as a commercial item as defined in FAR 2 101 a or as Restricted computer software as defined in FAR 52 227 19 whichever is applicable You have only those rights provided for such Software and Documentation by the applicable FAR or DFARS clause or the Sport Tech standard software agreement for the product General This Agreement shall be governed by and construed in accordance with the laws of the
41. e eta t Te Era te a Ene e dea Feet eta tatiana 46 4 12 Shoulder Anterior with external rotation sesssssssssseseeeeneneennene enne 47 4 12 1 Setting up the stress device ssssssssssssssseseseeeee eene nnne renes 47 4 12 2 Posrtionirig the patient eit etit tete erroe nat Pepe Re perte ANA 48 4 12 3 Entering positioning information in the LIGMASTER software a se 48 4 12 4 Acquiring Joint Force response data sssssssesseeeeeeene nene 49 4 12 5 Interpreting the diagnostic data ssssssssssseseseeeee ener nennen 49 4 12 6 Flow the test WOKS 1 5 creen estere tere et tenete te te tr dee Dept teh tecens le ine ete Due e aa ed cte end edad 49 4 13 Shoulder POSION eroinin etate nr site rete ete erts h dee bere nik Rete ala ida eacus 50 4 13 1 Setting up the stress device ssssssssssssssssseseeee enne enne nnns nnne en 50 4 13 2 Positioning the patient ssessssissssssseseeseeeee seen n nennen snnt enne snnt sinn sitet en 50 4 13 3 Entering positioning information in the LIGMASTER software s es 51 4 13 4 Acquiring Joint Force response data ssssessssessseeeeeeene nennen 52 4 13 5 Interpreting the diagnostic data sssssssssssseseeeeeeeeen nnne enne 52 4 13 6 How the test WOKS ungaran earan ATETA a FAA essen esee senten intr enint etnies SA nnne 52 4 14 Ankle Lateral Ligament sssesssseeeenee
42. e humerus is subluxed from the glenoid cavity while being restrained by the intact or remaining capsular ligaments The force subluxation relationship when plotted by LIGMASTER is represented by a straight line once the preceding compression of the soft tissues of the upper arm has been accounted for For the determination of the percentage tear including complete tear only the applied forces and the resulting humeral head displacements enter into the calculation but not the positions of the counterbearings However these positions should be registered and recalled for any subsequent or comparison exam in order to validate diagnostic interpretation LigMaster User s Manual Sport Tech Inc Page 46 4 12 Shoulder Anterior with external rotation Examiners may want to test the inferior gleno humeral ligament more specifically by examining the patient s shoulder in external rotation This can be easily performed at 90 degrees external rotation by positioning the lower arm in an upright position and strapping it to the distal counterbearing with velcro tape for stability and immobilization With experience you will be able to take a full set of diagnostic data for the shoulder with external rotation in less than ten minutes 4 12 1 Setting up the stress device For a shoulder test with external rotation set up the stress device as described under 4 11 1 and as shown below for the left shoulder If the test is based on a previous comparis
43. e leg and the midpoint of the pressure plate centered on the lateral aspect of knee joint space Figure 4 8 2 Right Knee mounted in stress device for MCL exam 4 8 8 Entering positioning information in the LIGMASTER software Once you have positioned the patient in the stress device you must enter the positions for each side arm If the test is based on a previous comparison the previous LIGMASTER settings will be recalled and can be used as a starting point for positioning the patient Acquire Test Data xj Readings Position the patient and record the ruler readings A and C Reading A mm 20 IV Check when value entered Reading C mm 420 Back Caes LigMaster User s Manual Sport Tech Inc Page 31 Because the pressure head must be located equidistant between the two counterbearings LIGMASTER will ask you to first enter the two counterbearing locations usually with A at 20 and C at 420 Once you have entered these numbers you must check the box on the right to verify the numbers Acquire Test Data x Readings Set position B to the following ruler reading Reading A mm 20 Set position B to fi 30 Check when position set Reading C mm 420 Cancel Once the A and C values have been entered and verified the value for B will be automatically calculated for you 4 8 4 Acquiring Joint Force response data Once you have
44. e most reliable source for comparison information However if that opposite joint has had a previous history of ligament injury its value as comparison may well be limited In clinical practice the opposite joint is often of questionable value only in case of lateral ankle ligaments Earlier studies have shown that ankle sprains occur more frequently among patients with a history of a previous sprain on the opposite ankle than in the population at large Up to one third of patients in one study could recall an injury to the opposite ankle ligaments when closely questioned A history of previous injury to the lateral ankle ligaments does not mean that the opposite joint can not serve as comparison only that its reliability has diminished LIGMASTER V s software has been adapted to allow for this clinical fact by automatically adjusting the comparison force strain line through the origin thereby projecting its presentation as normal even though this may not be the case As a result the test data for the ankle under examination are not presented and interpreted in absolute terms but only relative to that for the adjusted normal comparison LigMaster User s Manual Sport Tech Inc Page 65 6 Troubleshooting Sport Tech has made every effort to make using LIGMASTER as effortless and trouble free as possible If you have any difficulty using LIGMASTER M please see the list of common user problems below If your problem does not appear o
45. e two hands to insure that the increase in pressure is smooth and even It is best to increase the pressure by no more than 1dN every 2 3 seconds 30 45 seconds total Stop the exam if the patient experiences severe discomfort As you increase pressure you will see LIGMASTER updating the display in real time Once you have reached 15dN 12dN for the elbow MUCL and shoulder ligament tests hit the Stop button on the test and release pressure as quickly as possible by turning the handle backward Do not use the emergency release knob on the stress device for this purpose Once you have released pressure check the data display to make sure that the data was acquired correctly If the data looks good hit the Accept button to accept the test data If not hit the Cancel button and repeat the test as necessary Acquire Test Data x Acquire Data Acquire the data gt Auto Acquire Options Real Time Data Null until force exceeds dN o Force 0 00 aN Displacement 0 0 mm Start when force exceeds dN o Angle Stop when force exceeds dN fis Null Displacement tees LigMaster User s Manual Sport Tech Inc Page 22 4 5 2 Auto Acquire Method Auto Acquire mode will automatically Null the encoders start the test at a predefined force and stop the test at a predefined force 1 Verify that the Auto Acquire options are enabled and that the settings are correct Generally the Null and Start thresholds are set to z
46. ear expressed as percentage of remaining function and complete tear the relative positions of the counterbearings and the pressure actuator as well as the joint width are critical The latter has been assumed to average 87mm Any deviation from this average when compared with the opposite or same joint will not affect the diagnostic outcome of the exam but researchers may want to adjust this value for their specific purpose The Acquire Advanced box permits the examiner to do so LigMaster User s Manual Sport Tech Inc Page 33 4 9 KneeLCL The lateral collateral ligament of the knee can be readily examined by LIGMASTER With experience you will be able to take a full set of data for the LCL in less than 10 minutes 4 9 1 Setting up the stress device Before positioning the patient for a LCL test set up the stress device as shown below For most patients the side arms can be positioned in their extreme locations where A 20 and C 420 The pressure plate should be positioned with B at 190 and its center at the level of the knee joint space D Figure 4 9 1 Stress device settings for Knee LCL exam Y m Small patients or patients with short legs may require that the side arms are brought in closer to the pressure plate However the midpoint of the pressure plate with B at 190 should remain centered on the joint space and equidistant between the side arms If the test is based on a previous
47. ece is always used Figure 4 13 1 s v Stress device settings O for right posterior shoulder exam p ps i lil i The side arm closest to the patient with C 420 for the right shoulder A 20 for the left shoulder is positioned along the edge of the exam table and provided with the 80mm extension piece extending outwards A counterbearing is placed on the extension piece The pressure actuator is positioned so as to touch the proximal anterior aspect of the patient s upper arm The other side arm equipped with a counterbearing is positioned at the posterior aspect of the distal humerus Smaller patients can be accommodated in the stress device by relocating the positions of the counterbearings closer to the slide bar and or using the plastic extension piece for the pressure plate If the test is based on a previous comparison the previous LIGMASTER settings will be recalled and can be used as a starting point for positioning the patient 4 13 2 Positioning the patient The patient is requested to sit down on an adjustable height stool with the shoulder abducted 90 degrees and the elbow flexed 90 degrees The counterbearing closest to the patient and mounted on the extension piece is positioned on the scapular spine The pressure plate is positioned at anterior aspect of the proximal humerus and the LigMaster User s Manual Sport Tech Inc Page 50 other counterbearing at the posterior aspect of the distal hum
48. ent Ligament Extension mm 6 8 10 12 14 1818 20 eee 1 24 26 28 1 1 1 L 1 1 1 1 1 1 an example of patient E movement during an ACL B m exam During this test the patient shifted twice once at 3dN and again at 7dN Because of the horizontal gaps in the graph which are caused by patient movement this test should be rejected Repeat testing usually helps the patient to relax and avoid shifting position during testing Force dN LigMaster Doe John E Patient Test View Tools Help Apparent Ligament Extension mm 5 10 15 20 25 30 35 40 Doe John Force dN la xl plan eren Iove gen ien en od es e ee eT 0 0 05 01 015 02 025 03 035 04 045 05 055 06 065 07 075 08 085 09 Ligament Strain 4 1 4 LigMaster User s Manual Sport Tech Inc T T T T T T T T T 05 0 6 0 7 0 8 09 1 14 ihe T3 14 Ligament Strain A 1 A The display on the left shows an example of a knee MCL test where the patient leaned into the pressure plate A vertical series of points at the beginning of this test indicate that this test should be rejected Repeat testing usually helps the patient to relax and avoid tensing during testing Page 63 The display on the right shows an example of an MUCL test where the test elbow shown in red is dragging against the examination table during the beginning of the test Note that when the tip of the elbow is dragging on the table a larger force is requ
49. entered and verified the patient positioning data you are ready to apply force to the joint and to collect data on the resulting joint response See section 4 4 on acquiring test data 4 8 5 Interpreting the diagnostic data The extent of damage to the MCL can be assessed by comparison of the test results with those of the normal opposite MCL or pre injury same MCL Because of the absence of bulky soft tissue on the lateral aspect of the knee the force strain relationship is determined in the first place by the integrity of the MCL and only secondarily by the elastic compression of the soft tissues nearest the counterbearings and their rubber coverings The initial slope therefore represents the tensile properties of the MCL This slope is reduced for partial tears proportional to the percentage tear For complete tears the line no longer goes through the origin but is displaced to the far right of the screen Slack in the MCL can be quantified from the point of intersection of the line with the x axis but considerable slack may be difficult to distinguish from complete tear LigMaster User s Manual Sport Tech Inc Page 32 4 8 5 How the test works By applying force to the lateral aspect of the knee joint space the medial joint space widens and confers a stretching force to the MCL The extent of medial joint space widening is proportional to the remaining function of the MCL For the diagnostic distinction between normal partial t
50. erator Most new users will begin by using LIGMASTER in Manual mode and switch to Auto Acquire when they have gained proficiency Regardless of which method is used the data acquisition always begins by positioning the pressure plate until it is just touching the pressure application point You should see a Force reading in the Hea Time Data display on the right when a slight pressure is applied to the application point If you do not see a Force reading the software is not communicating to the stress device properly If you are measuring ankle data you should also see an Angle reading If there is Force data but no Angle data you may not have the rotary encoder cable installed correctly Check your connections and refer to the troubleshooting guide if necessary The next steps will depend on whether you are using the Manual or Auto Acquire method LigMaster User s Manual Sport Tech Inc Page 21 4 5 1 Manual Method 1 Apply a small 1 dN force and then slowly reduce the pressure until Force reads 0 00dN Hit the Null button This sets the starting displacement to zero If you are measuring ankle ligaments the Angle value will also be set to zero Press Start The dialog box will now close and you will see the data acquisition screen This screen will show Force and Strain data calculated in real time as you conduct the test Increase the pressure by turning the pressure handle slowly and consistently It is best to us
51. ero and the Stop threshold is set to 15 12 for the elbow MUCL and shoulder ligament tests 2 Press Start The dialog box will now close and you will see the data acquisition screen Once the Start Force threshold has been reached the screen will show Force and Strain data calculated in real time as you conduct the test 3 Increase the pressure by turning the pressure handle slowly and consistently It is best to use two hands to insure that the increase in pressure is smooth and even It is best to increase the pressure by no more than 1dN every 2 3 seconds 30 45 seconds total Stop the exam if the patient experiences severe discomfort As you increase pressure once you reach the configured Start force you will see LIGMASTER M updating the display in real time 4 Once you have reached the configured stop force LIGMASTER will stop collecting data Release pressure as quickly as possible by turning the handle backward Do not use the emergency release knob on the stress device for this purpose 5 Once you have released pressure check the data display to make sure that the data was acquired correctly If the data looks good hit the Accept button to accept the test data If not hit the Cancel button and repeat the test as necessary Acquire Test Data x Acquire Data Acquire the data r Auto Acquire Options r Real Time Data J Null until force exceeds dN o us 0 00 dN Displacement 0 0 mm JV Start when for
52. erus The patient is requested to sit up straight not to slump and to relax the arm muscles Figure 4 13 2 Left Shoulder mounted in stress device for posterior exam 4 p The integrity of the posterior slip of the inferior gleno humeral ligament is optimally examined by applying a force posteriorly to the elbow joint with the shoulder flexed 90 degrees internally rotated and the elbow flexed 90 degrees LigMaster is not capable of stressing the shoulder in that position but the above described technique examines instead the overall posterior stability including the contribution of the posterior aspect of the labrum x Readings Set device positions to the following ruler readings Set position A to n 0 IV Check when position set Set position B to 342 IV Check when position set Set position C to 420 IV Check when position set lt Back Cancel 4 13 3 Entering positioning information in the LIGMASTER software Once you have positioned the patient in the stress device you must enter the positions of each side arm and the pressure actuator For examining the right shoulder C is always 420 but the positions of B and A depend on the length of the patient s arm Similar considerations apply to the left shoulder for which A is always 20 LigMaster User s Manual Sport Tech Inc Page 51 If the test is based on previous comparison the previous LIGMASTER settings will be recalled
53. evice you must enter the positions of each side arm and the pressure actuator For examining the right shoulder A is always 20 but the positions of B and C depend on the length of the patient s arm For the left shoulder C is always 420 If the test is based on a previous comparison the previous LIGMASTER settings will be recalled and can be used as a starting point for positioning the patient Once you have entered these numbers you must check the box on the right to verify the numbers LigMaster User s Manual Sport Tech Inc Page 44 Acquire Test Data x Readings Set device positions to the following ruler readings Set position A to 310 v Check when position set Set position B to 342 V Check when position set Set position C to 420 v Check when position set lt Back Cancel 4 11 4 Acquiring Joint Force response data Once you have entered and verified the patient positioning data you are ready to apply force to the joint and to collect data on the resulting joint response See section 4 4 on acquiring test data Note that the maximum force for the shoulder ligament test should be no more than 12 dN 4 11 5 Interpreting the diagnostic data The extent of injury to the capsule ligaments of the gleno humeral joint can be assessed by comparison with the data from the opposite normal joint or pre injury same joint The force strain relationship shows an initial linear part representing comp
54. f each side arm and the pressure actuator For most patients A will be at 20 and C at 420 but patients with short legs may require that the side arm holding the counterbearing is brought in closer to the pressure actuator If the exam is based on a previous comparison the previous LIGMASTER settings will be recalled and can be used as a starting point for positioning the patient Once you have entered the numbers you must check the box on the right to verify the numbers Acquire Test Data x Readings Set device positions to the following ruler readings Set position A to 20 v Check when position set Set position B to 272 v Check when position set Set position C to 420 v Check when position set lt Back Cancel LigMaster User s Manual Sport Tech Inc Page 59 4 15 4 Acquiring Joint Force response data Once you have entered and verified the patient positioning data you are ready to apply force to the joint and to collect data on the resulting joint response See section 4 4 on acquiring test data 4 15 5 Interpreting the diagnostic data Testing the medial ankle ligaments involves the compression of less soft tissue than that of the lateral ligaments As a result the initial part of the force strain relationship is representative of medial ligament stretching with the reduction of the slope proportional to percent tear The deltoid is a broad fan shaped ligament that tears in eversion in
55. h the edge of the table The extremity to be examined is extended sideways and positioned with the counterbearing level with the proximal humerus and the elbow flexed 15 degrees The wrist is supinated and fixated in the wrist holding device as illustrated in figure 4 10 2 Make sure that the patient is sitting upright chest out and upper arm touching but not leaning into the counterbearing Upper arm and lower arm should make the same angle with respect to the table surface and the tip of the elbow should not touch the table Figure 4 10 2 Right Elbow mounted in stress device for MUCL exam P EP Figures 4 10 2a c sequence of fixating wrist in stress device for MUCL exam LigMaster User s Manual Sport Tech Inc Page 40 4 10 3 Entering positioning information in the LIGMASTER software Once you have positioned the patient in the stress device you must enter the positions for the side arm closest to the patient and that of the pressure plate in the positioning information boxes For the right MUCL that is A at 20 and B at the elbow joint space with the elbow flexed 15 degrees For the left MUCL C is at 420 and B at the joint space of the flexed elbow Acquire Test Data 1 xj Readings Position the patient and record the ruler reading B Set position A to 20 IV Check when position set Reading B mm 1170 IV Check when value entered lt Back Cancel Once you have entered the position for side
56. hered by encoders mounted on the stress device without the use of x rays and with an accuracy that permits the computation of the percentage ligament tear in each of the ligaments involved In addition hypermobility and or instability of the subtalar joint can be assessed as well without the need to perform additional examinations LIGMASTER can also provide indirect information on syndesmotic injury by determining the extent of lateral ligament involvement with which the likelihood of tibio fibular involvement in the clinical setting of an ankle sprain is associated LIGMASTER s examination of the cruciate ligaments is the instrumented version of the classical Lachman or anterior drawer test permitting an accurate assessment of remaining ligament function The posterior cruciate is equally accessible The MCL and LCL of the knee can be examined by LIGMASTER by positioning the patient supine and applying the force medially and laterally respectively The medial ulnar collateral ligament of the elbow can be examined by mounting the elbow in the stress device with the forearm in supination The exam is the instrumented equivalent of the gravity test used to detect joint widening as a result of collateral ligament insufficiency using X rays LIGMASTER can assesss capsular ligamentous insufficiency of the humero glenoid joint with the same stress device used for ankle knee and elbow ligament evaluation Both anterior and poster
57. ior laxity with the shoulder in neutral internal or external rotation can be quantitatively determined The clinical actuality of this diagnostic exam renders this unique and unmatched capability one of the finest features of the LIGMASTER system LigMaster User s Manual Sport Tech Inc Page 69 LigMaster User s Manual Sport Tech Inc Page 70 9 Appendix B Technical Summary The data collected by LIGMASTER s encoders are processed by software that uses graded stress technology GST to arrive at a diagnosis in terms of percentage ligament tear Two aspects determine the clinical significance of a specific percentage tear 1 Ligaments are not of a homogeneous composition Their fibrous make up has been identified as consisting of different elements collagen elastin nerve elements etc that contribute to the overall visco elastic properties of the ligament under investigation In injury the weakest elements of a ligament may be the first to tear and in case of a partial tear the strongest fibers may remain intact As a result a certain percentage partial tear is expressed by GST as loss of percentage function rather than as loss of percentage anatomical damage 2 GST is based on the principle that stressed ligaments will follow for small elongations the visco elastic behavior elastomers That is the ligaments initially yield to stress in the same way as ideal rubber deforms under load Here the force F applied
58. ired to overcome this resistance The examiner should always make sure that the joint under examination is able to move freely during the exam LigMaster User s Manual Sport Tech Inc Patient Test View Tools Help Force dN Apparent 4 MUCL Extension mm 6 8 1 1 10 1 i 14 16 18 20 22 Doe John Ligament Strain 1 102 Page 64 5 Diagnostic aids To optimally use the results from your LIGMASTER exam several diagnostic aids to validate your findings are listed below New aids will be added as more information from LIGMASTER users like you becomes available through our website at www ligmaster com The acquired force displacement curves for injured ligaments should always be compared with the results for a set of normal ligaments in the same patient Patient to patient variability is generally too large to make a comparison with normal ligaments of other patients useful even if allowance is made for gender and age Preferably the comparison should be the pre injury same ligaments and we strongly recommend collecting baseline information by LIGMASTER on the most commonly injured ligaments if trauma is likely to occur eventually Clearly this recommendation applies in the first place to athletes who are more likely to incur specific ligament injuries than the population at large If no pre injury data by LIGMASTER is available the opposite joint of the same patient is th
59. isplacement mm gnostic Summary F z 6 8 2 6 Z z zx 2 z X rx c I l T Patient name Doe John 2 Doe John Last seen Thu Mar 07 13 10 14 2002 i Test Right Shoulder Anterior w o ext rot M MORE RR Date Thu Mar 07 15 29 33 2002 m Mr zz 150 Comparison Right Shoulder Anterior w o ext rot Date Thu Mar 07 15 30 49 2002 Force dN Test analysis initial x intercept 0 02 xi initial slope 3 73 angulation at 1 1378 21 final slope 22 16 1 RIghi Steulder Anterior wo ext Mex Of Zn 1525 Ligament Specify the ligament to be tested Comparison analysis initial slope 4 57 angulation at 1 1438 21 final slope 23 84 T 1 pez d 42 Ie dp ct knee ACL z o of os Shoulder Anterior w o ext The Test has more laxity Percentage Increased L Shoulder Posterior Ankle Lateral Ligs Ankle Medial Deltoid LigMaster User s Manual Sport Tech Inc Page 17 If the patient is very large or small you may also have to re arrange the components of the stress device to allow for the patient s anatomy see considerations for each ligament You may also want to adjust the patient anatomic parameters that LIGMASTER uses to model the joint and ligament interaction This is done by clicking the Advanced button in the test select dialog box Note Setting patient anatomy values is for advanced users only Improper value
60. istance traveled by the pressure plate and the applied force are required The use of these types of sensors enables the interface board to digitize and communicate with the diagnostic software The use of electronic sensors linked to an interface board allows the diagnostic software to acquire digital input of the measurements from the sensors Electrical communication between encoders and the interface board can be conveniently established using standard telephone wiring but adaptations to data transmission using infra red or any other wireless or wired technology are well within the scope of our new technology Trigonometric formulas manipulate the data gathered by the sensors to compute the joint space widening from which the stretching of the ligaments under examination is assessed From the relationship between applied force and ligament elongation the number of remaining fibers in the ligaments can be calculated and thereby the percentage ligament tear Literature references to the GST system and its clinical validation have appeared in Clinical Orthopedics and Related Research American Journal of Sports Medicine Radiologica Acta Orthopedics Today Contemporary Diagnostic Radiology The Physician and Sportsmedicine The Journal of Bone and Joint Surgery and other journals Interested readers are referred to Sport Tech s website at www ligmaster com LigMaster User s Manual Sport Tech Inc Page 85
61. l Sport Tech Inc Page 61 5 ioraster poeson 9 umi Patient Test View Tools Help The display on the right shows Capsular Displacement mm 2 4 6 8 10 12 14 16 48 2 2 24A ay 3 W an example of inconsistent aM I patient positioning The initial HB oe omn slope is the result of soft 13 tissue compression which 2 Tes should be consistent from test n Left Shoulder Anterior ext ae to test in this shoulder patient 0 Inconsistencies in the initial slope indicate that the patient was not positioned properly Force dN Oo gt N a A OG og T T 07 08 0 Capsular Strain o 1 o ziBixd Patient Test View Tools Help Apparent Capsular Displacement mm 6 8 2 4 10 12 14 16 18 20 22 24 26 28 30 32 34 1 1 1 1 L 1 1 1 1 1 1 1 1 1 fi 174 Doe John The display on the left shows an example of jitter during a shoulder test This can occur if the operator does not apply force evenly or if the patient tenses during the test To get a smooth consistent plot the patient should be relaxed and force applied slowly and consistently by the operator Force dN nterior w ext rot 26 OQ N Q amp Oo 40 qo T T T T T T n min A2 qus 0s 0S AE 07 087 Wey E e REIS e R Ht 1 Capsular Strain 4 1 4 LigMaster User s Manual Sport Tech Inc Page 62 LigMaster Doe John j Patient Test View Tools Help The display on the right shows Appar
62. lf with the capabilities of LIGMASTER M loxi Patient Test View Tools Help LigMaster Diagnostic Summary 7 Capu Tana u 6 8 om Da w 1 Patient name Doe John E Last seen Thu Mar 07 13 10 14 2002 D Doe John Test Right Shoulder Anterior w ext rot i Date Thu Mar 07 15 26 43 2002 o 3 RightStonker areor a en rot Mar O7 A 1524 Comparison Right Shoulder Anterior w ext rot Date Thu Mar 07 15 24 37 2002 Force dN Test analysis initial x intercept 0 01 initial slope 4 50 angulation at 0 9672 16 93 mm final slope 25 37 tStoug r Are rior wert rol Mar Or A02 1526 get 171mm Comparison analysis T T T T T T T T iJ initial slope 4 70 a2 di O of 02 o3 of os of of og o d dw m angulation at 0 8911 15 23 mm Capsular Strain o1 o final slope 22 79 Shoulder Anterior w ext rot diagnosis The Comparison has more laxity Percentage Increased Laxity 11 3 2 4 1 Plot and Summary views LIGMASTER test data can be displayed in two formats selectable from the View menu The Plot view shows a full resolution plot of the test data while the summary view shows a smaller version of the plot with diagnostic information HTLTITST HEN E Pat Tei Vew Took rb LigMaster Diagnostic Summary nog Pebert na Last seen 144 124 t rot lz 124 g d n ha 1
63. lope 22 79 Elbow MUCL Right Mar 07 2002 15 11 Elbow MUCL Right Mar D7 2002 15 08 Shoulder Anterior w ext rot die L The Comparison has more laxi Select Test Percentage Increased Laxity Test Edit Comparison Delete Deselect Cancel Apply To select a test click on one of the tests in the list with the left mouse button This will highlight the test Then click on either the Test or Comparison button to identify the highlighted test When you hit the OK button the new test and comparison if applicable will be displayed LigMaster User s Manual Sport Tech Inc Page 12 2 4 3 Evaluating the Tests As you go look through the fictional patient database you will notice that there are several sets of data for each joint Two of these tests are of a healthy ligament They will show some slight variation due to small differences in patient positioning or changes in soft tissue composition However they are the same within a few percent The other data sets are the same ligament with varying grades of injury Notice how they compare to a healthy ligament With practice an experienced LIGMASTER operator can predict percent ligament damage with a high degree of accuracy The figure below shows a stress exam for the shoulder in which the test has about 796 more laxity than the comparison which indicates no significant injury in clinical terms Appendix C shows the screen shots for the various grades of inj
64. ls Help analysis edit the test few i data for the comparison DOPUYTLR t porpor of p Patient name Doe John el Doe John ankle in the Test Select Last seen Thu Mar 07 13 10 14 INNI c E box and click on the bar Test Right Anke Late Ty thi H Date Thu Mar 07 13 i this li ament has a A MET IEEE g tai EH Comparison Left Ank Eon MU Bg Mart XX RT history of injury in the Date Thu Mar 07 13 EbowMucs Aka AER di b Th Elbow MUC Edit Test Data x la ogue OX e Test analysis Ankle Medi Ligament Annotations Readings Corroborating Diagnosis Data Diagnostic Summary will irm tirs 1 nkle Latet report the ligament Comparison analysis 4 ESTE status accordingly In slope 11 49 Es cases of an uncertain or E Pun forgotten history on the E F IV This ligament has a history of injury opposite ankle the l Ankle Lateral Ligs d i Th l vanced examiner Can compare ie e Advanced the results by ppv of grade l I 14 i f 0 working up the stress ppv of grade IV X results for both scenarios and compare consistency LigMaster User s Manual Sport Tech Inc Page 56 4 14 6 How the test works By applying force to the medial aspect of the distal tibia the tibiotalar joint space widens laterally and stretches the lateral ligaments from which the extent of injury is determined The extent of lateral joint space widening is proportional to the width of the ankle joint assumed to
65. may accompany ligament damage As is the proper procedure with conventional stress studies associated injury if suspected may need to be excluded before proceeding with LIGMASTER after the initial injury All subsequent stress exams can then be done safely with LIGMASTER M alone Two major features set LIGMASTER apart from conventional stress devices J 1 There is no need to take X rays for the determination of the talar tilt angle the anterior posterior drawer of the knee elbow joint widening or shoulder subluxation This has the important consequence that stress exams no longer require a hospital setting including appointments radiology facilities personnel and patient exposure to ionizing radiation Instead the stress exam can be performed by qualified athletic trainers coaches office nurses and paramedics requiring only minimal computer skills As a result a more liberal use of stress exams and stress devices has become feasible 2 Unlike conventional stress exams that yield information on joint laxity only LIGMASTER provides full details on the extent of ligament tear using the graded stress technique GST This technique can distinguish complete rupture from partial LigMaster User s Manual Sport Tech Inc Page 68 tear with the latter expressed in percentage functional loss Slack in a ligament frequently the result of earlier trauma can not only be identified but accurately assessed These features are significa
66. n existing diagnostic devices by offering superior diagnostic capability at less expense in less time and with greater ease of use all in a portable package 1 2 The LIGMASTER System The LIGMASTER system consists of two parts 1 a specifically modified Telos GA II E stress device that has been fitted with a custom electronic sensor package mounted on the stress device and 2 a software package that performs all necessary calculations to produce a diagnosis of ligament injury in terms of percentage lost or regained function To perform an examination the technician positions the joint under investigation in the stress device and turns a knob to apply a gentle measured force The sensors measure force induced changes in the joint s position and the software compares the result with LigMaster User s Manual Sport Tech Inc Page 6 data from a comparison exam The latter can be acquired from a previous study of the same uninjured joint or from examining the opposite normal joint The data from the two exams are then used to arrive at a diagnosis of ligament damage in terms of percentage ligament tear or recovery Clinical and technical considerations relating to LIGMASTER M are discussed in Appendices A and B Space requirements for LIGMASTER are nominal The stress equipment including the electronics comes in a portable briefcase size hardcover container and does not take up fixed space It is ready for use wherever it
67. n this list please contact Sport Tech from the www ligmaster com website 6 1 Acquire data menu does not show force and displacement readings If you do not see real time data updating in the acquire data menu first make sure that the USB cable is securely connected to both the computer and LIGMASTER stress device Then exit and restart the LIGMASTER software The USB cable must be attached before starting the software program If this does not solve the problem check the USB cable the majority of field problems are due to cabling If a new cable does not solve the problem contact Sport Tech 6 2 Thetest curve abruptly turns into a vertical er line A The pressure head of the stress device has run out of al travel and can no longer move forward Remount the zal 44 patient and either put the counterbearings in a closer y position or add the extension piece to the pressure A head 6 3 The response curve for an ankle seems to be A abnormally steep E eus The cable from the pressure head to the rotary d d encoder is not connected properly Check the cabling 1 and repeat the test Force dN 6 4 A portion of the test curve turns into a vertical line The LIGMASTER device has developed a dead band in its linear encoder Contact Sport Tech to arrange for servicing Force dN ss 73 04 as os o7 os Ligament Strain i i LigMaster User s Manual Sport Tech
68. neneenenen AAEE prani iepa en nnns nennen nnns 53 4 14 1 Setting up the stress device ssssssssssssssssss ener enne nnns nnne en 53 4 14 2 Positioning the paien arosai a esseeeeeeseenn nennen nennen nennen essentia 53 4 14 3 Entering positioning information in the LIGMASTER software sssssseeeee 54 4 14 4 Acquiring Joint Force response data sssesssesseeeneeeenenenenen nennen 55 4 14 5 Interpreting the diagnostic data sssssssssssseseseeee eene nnne 55 4 14 6 HOW INE LOST WOTKS 3 cre cec edet re detener tte tr cde cepa Deb tenera tete Bo due Dee asa tette nda 57 4 15 Ankle Medial Deltoid iessessssessssssesesesenee ener nnne trt en nennt snnt senes 58 4 15 1 Setting up the stress device sssssssssssssssssseeenee enne nennen nennen snnt en 58 4 15 2 Positioning the palchi ziaes Aa AEE ANT e AEEA e AR i AAE nennt inneren nitens 59 4 15 3 Entering positioning information in the LIGMASTER software 59 4 15 4 Acquiring Joint Force response data sssssssessseeeeeeeenenen eene 60 4 15 5 Interpreting the diagnostic data ssssssssssssssseseee eene enn 60 4 15 6 How the test works nireari igarot SARE aE Saa FAA ASAE AEEA EA PAT AESAAT AEE San UATE 60 4 16 LigMaster repeatability and accuracy ssssssseseseeeeeenenene enne ener 61 Briele go aiae a DELETE 65 Troubleshooftlig iic eite
69. njured ligaments in athletic practice LIGMASTER can readily determine the involvement of each of these ligaments in ankle sprains With experience you will be able to take a full set of diagnostic data for a sprained ankle in less than ten minutes 4 14 1 Setting up the stress device Before positioning the patient for an ankle exam set up the stress device as shown below If the test is based on a previous comparison the previous LIGMASTER settings will be recalled and can be used as a starting point for positioning the patient Note Do not forget to connect the rotary encoder cable I Figure 4 14 1 Stress device settings for right lateral ankle exam Ii 4 14 2 Positioning the patient The patient is requested to sit up on the examination table supporting him herself on outstretched arms behind his her back the beach position as shown in the illustration The leg under examination is extended the opposite leg is flexed at the knee The ankle holding device is placed in position and the heel is fixated in the ankle holder Make sure that the heel is deeply seated and relaxed before the grip on the calcaneus is tightened by turning the handle Next a counterbearing is placed near the knee A cushion under the upper part of the leg close to the slightly flexed knee greatly adds to the patient s comfort When examining the opposite ankle for comparison always make sure to begin the exam with
70. not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you LigMaster User s Manual Sport Tech Inc Page 3 Table of Contents 1 INMTOCUICUION E EE 6 Ved EIGMASTER TIM Benefits 4 e reet rant etie reru ad es a D E BOR bae Pa rte ra REL E eR 6 1 2 The EIGMASTERIM SyStOem 22 iecit tae t e netu Heu ee ect e eee t ore eiut 6 1 3 LIGMASTER Advanced Diagnostics etisi tirthe enin Ane eene nnne nennen nns 7 1 4 About Sport Lech eate ettet eet e Eee Rieti d ee Peto ta ru dona 7 2 Getting Started aie reete i m Dp biet an ete eot Beech ro feet aD ea eode 8 231 Before VOU Start i ope cet eie t e dee aude e ete ints eee aeo Pe eat teed 8 2 2 Installing the SORWare vats iie eee ette e t t tt Deest o a o etu dined 8 2 3 Setting Up and Connecting the Stress Device sse 9 2 4 Getting familiar with the LIGMASTER software ccccccceeeeeeeeeeeeeeeeeeeecaeeeeaaeeeceeeseaeeesaaeeseneeeeaees 11 24 1 Plotand Summary VIEWS a mtse a ai aeara tee ice eret e dete e bate hares d ang 11 2 4 2 Selectihg Testes te ere tb e deside n sae loe ASEEN 12 2 43 Evaluating the T 6sts irt bee ete ee Ueber e ed tbe apt celsa tod 13 2 4 4 Viewing the raw test dala eene ek e Uk pl eek xu edv e Decke Eo eoe REL 14 3 Using the patient database ier eec e nl iet eite e leek bras neis vehi ae tee redeo 15 3 1 Adding a NEW pal
71. nt because it has been well established that all other things being equal the prognosis of conservatively managed ligament injury is determined by the extent of ligament damage incurred at the time of trauma The treatment of choice of ligament injury is usually dependent on extent of tear partial tears of the ACL and the MUCL can usually be treated conservatively if less than 5095 whereas larger partial tears and complete tears do better with surgery at least in athletes Grade and II ankle ligament tears have a good prognosis when managed with ice rest bracing and a measure of mobilization but grade Ill and particularly grade IV are likely to continue to trouble the patient unless treated more aggressively which may include surgery So it is evident that both patient and health care provider greatly benefit from an early diagnosis in terms of a quantitative assessment of ligament damage Conventional stress studies on the other hand can provide at best only a qualitative estimate of the injury a level of joint laxity that on comparison with the opposite joint may or may not indicate ligament involvement but not the grade of injury or the exact extent of tear Inversion and eversion injury to the lateral and medial ankle ligaments is associated with lateral and medial widening of the tibio talar joint that can be evoked manually or with stress devices using X rays LIGMASTER calculates the ensuing talar tilt angles from data gat
72. o the far right of the screen Slack in the LCL can be quantified from the point of intersection of the line with the x axis but considerable slack may be difficult to distinguish from complete tear LigMaster User s Manual Sport Tech Inc Page 37 4 9 6 How the test works By applying force to the medial aspect of the knee joint space the lateral aspect of the joint widens and confers a stretching force to the LCL The extent of lateral joint space widening is proportional to the remaining function of the LCL For the diagnostic distinction between normal partial tear expressed as percentage remaining function and complete tear the relative positions of the counterbearings and the pressure actuator as well as the joint width are critical The latter has been assumed to average 87mm Any deviation from this average when compared with the opposite or same joint will not affect the diagnostic outcome of the exam but researchers may want to adjust this value for their specific purpose The Acquire Advanced box permits the examiner to do so LigMaster User s Manual Sport Tech Inc Page 38 4 10 Elbow MUCL The medial ulnar collateral ligament of the elbow can be readily examined by LIGMASTER M With experience you will be able to take a full set of diagnostic data for the MUCL in less than ten minutes 4 10 1 Setting up the stress device Before positioning the patient for an elbow MUCL test set the stress device up as shown
73. on the previous LIGMASTER settings will be recalled and can be used as a starting point for positioning the patient Figure 4 12 1 G O Stress device settings for left anterior shoulder exam with 80mm extension gt mp LigMaster User s Manual Sport Tech Inc Page 47 4 12 2 Positioning the patient The position of the patient when examining the shoulder in external rotation is the same as described under 4 11 2 except that the flexed lower arm is now pointing upwards The lower arm is stabilized using the wrist support frame as illustrated in Fig 4 12 2 Make sure that the patient is sitting upright chest out and touching but not leaning into the counterbearing Also make sure that the patient is not slumping with the shoulder falling away from the counterbearing The arm muscles should be relaxed Figure 4 12 2 Right Shoulder mounted in stress device for anterior exam with external rotation ILIUM Tee p D VIC 4 12 3 Entering positioning information in the LIGMASTER software Once you have positioned the patient in the stress device you must enter the positions of each side arm and the pressure actuator Follow the procedures described under 4 11 3 LigMaster User s Manual Sport Tech Inc Page 48 Acquire Test Data x Readings Set device positions to the following ruler readings Set position A to 310 IV Check when position set Set position B
74. order to proceed When you ve entered all of the patient s information that you need hit OK You are now ready to take test data for the patient LigMaster User s Manual Sport Tech Inc Page 15 3 2 Selecting a patient Once you have entered information on a particular patient you may access the same patient at a later point in time by selecting Open Patient from the File menu This will open the Select Patient dialog box Whenever you select a patient from the Select Patient dialog box the current patient file is closed and the selected patient file is opened When a patient is selected all tests performed previously on the selected patient become available from the Test menu New tests can be added and compared with previous tests ip Patient Test View Tools Help New er Diagnostic Summary Capsular Displacement mm Edit 10 15 zm z5 Export name Doe John Doe John ae Thu Mar 07 13 10 14 2002 Test Right Shoulder Anterior w o ext rot NEN o Date Thu Mar 07 15 29 33 2002 Mer Ot znz emm Comparison Right Shoulder Anterior w o ext rot Date Thu Mar 07 15 30 49 2002 Test analysis 3 f initial x intercept 0 30 CNN initial slope 3 73 p nn ME angulation at 1 4087 28 09 mm final slope 22 16 A ot Comparison analysis Nov 16 2001 16 38 initial x intercept 0 27 oe Mar 07 2002 13 10 initial slope 2 4 57 angulation at 1 4148 28 2 final slope 23 84 1 14 12 13 314 15 16 17 18 15 Strain o
75. ostic data The force strain data collected on screen in real time provide the key to the diagnostic interpretation of the test results see How does LIGMASTER work in section 10 3 In PCL testing the pressure plate is positioned just distal to the tibial tuberosity and unlike in ACL testing the applied force acts directly upon the PCL without first having to compress a large soft tissue mass This results in an essentially straight line relationship between force and strain in which the contributions of soft tissue compression of the hamstring Achilles tendon and the foam rubber of the counterbearings are accounted for The latter contributions are the same for the comparison test and do not interfere with the diagnostic interpretation Partial tears are characterized by a reduction of the slope with respect to the comparison line for the normal PCL with both lines going through the origin As with the ACL the extent of reduction is proportional to the percentage PCL tear In complete PCL tears the line usually shows a different slope and is well removed the right intersecting the x axis Slack in the PCL also shows as intersection of the x axis with the line running parallel to that of the comparison test However in clinical practice large slack can occasionally be difficult to differentiate from complete tears The diagnostic dialog box summarizes the results in the left hand column LigMaster User s Manual Sport Tech Inc
76. play E a Fa rupture for Lateral ankle ligament injury Figure C 28 Grade IV injury Normal ATF and CF Slack in ATF Figure C 29 Slack in ligaments and CF LigMaster User s Manual Sport Tech Inc Page 82 Medial Ankle Ligs Diagrammatic examples of Normal LigMaster diagnostics display deltoid ligs F for Medial ankle deltoid Fa E ligament injury i P Partial tear of j deltoid ligs Figure C 30 Partial tear deltoid ligs Normal P i deltoidligs Complete tear Of deltoid ligs Figure C 31 Complete tear deltoid ligs Normal deltoid ligs Slack in Figure C 32 Slack in deltoid ligs ra E deltoid ligs LigMaster User s Manual Sport Tech Inc Page 83 11 Commonly asked questions 11 1 What kind of computer should I get LIGMASTER can run on any laptop or desktop computer with a USB port CD drive and Windows 98 2000 XP operating system LIGMASTER requires as little as 10Meg of free hard drive space and can run in 2Meg of memory Sport Tech recommends at least a 200Mhz processor for real time data display If you have an existing computer that meets the above requirements it will have no problems running LIGMASTER M In the event that you must purchase a new computer any computer with a USB and Windows 98 2000 XP will provide more than enough horsepower If portability is a concern you may consider a notebook computer although these tend to be a bit more expensive than
77. play Partial ACL for ACL ligament injury Figure C 1 Partial ACL Tear Normal ACL Figure C 2 Complete ACL Tear e Complete we ACL Tear ow we Figure C 3 Slack in ACL LigMaster User s Manual Sport Tech Inc Page 73 PCL Diagrammatic examples of Normal PCL LigMaster diagnostics display for PCL ligament injury P Partial Tear r PCL Figure C 4 Partial Tear PCL Normal PCL d Complete Tear PCL Figure C 5 Complete Tear PCL Normal PCL Nur a Slack in PCL Sow Figure C 6 Slack in PCL da LigMaster User s Manual Sport Tech Inc Page 74 MCL Diagrammatic examples of LigMaster diagnostics display for MCL ligament injury Figure C 7 Partial Tear MCL Figure C 9 Slack in MCL Normal MCL Partial Tear MCL Complete Tear MCL Figure C 8 Complete Tear MCL N IMCL orma Pad Slack in MCL oe LigMaster User s Manual Sport Tech Inc Page 75 LCL Diagrammatic examples of Normal LCL LigMaster diagnostics display for LCL ligament injury d Partial Tear LCL Figure C 10 Partial Tear LCL Complete Tear LCL Figure C 11 Complete Tear LCL Slack in LCL Figure C 12 Slack in LCL LigMaster User s Manual Sport Tech Inc Page 76 Normal MUCL gt ra SE PO MUCL Diagrammatic examples of LigMaster diagnostics display for MUCL ligament injury z s x i Parti
78. port Tech will replace software media that does not execute its programming instructions due to such defects 3 Sport Tech does not warrant that the operation of Sport Tech products will perform without interruption or error If Sport Tech is unable within a reasonable time to repair or replace any product to a condition as warranted you are entitled to a refund of the purchase price upon prompt return of the product 4 Warranty does not apply to defects resulting from a improper or inadequate maintenance or calibration b software interfacing parts or supplies not supplied by Sport Tech c unauthorized specifications for the product or e improper site preparation or maintenance 5 ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE IS LIMITED TO THE DURATION OF THE EXPRESS WARRANTY SET FORTH ABOVE Some states or provinces do not allow limitations on the duration of an implied warranty so the above limitation or exclusion might not apply to you This warranty gives you specific legal rights and you might also have other rights that vary from state to state or province to province 6 THE REMEDIES IN THIS WARRANTY STATEMENT ARE YOUR SOLE AND EXCLUSIVE REMEDIES EXCEPT AS INDICATED ABOVE IN NO EVENT WILL Sport Tech BE LIABLE FOR LOSS OF DATA OR FOR DIRECT SPECIAL INCIDENTAL CONSEQUENTIAL INCLUDING LOST PROFIT OR OTHER DAMAGE WHETHER BASED IN CONTRACT TORT OR OTHERWISE Some states or provinces do
79. portional to the percentage MUCL tear and relative to the comparison uninjured MUCL For complete tears of the MUCL the point of angulation between the two lines is moved well to the right on the screen and the second part of the slope is usually less steep than the normal comparison slope Slack in the MUCL can be quantified from the points of intersection of the second parts of the slopes with the x axis but considerable slack may be difficult to distinguish from complete tear LIGMASTER provides the capability to disable any points in the graphs When the contribution of certain points are considered to be unhelpful to the interpretation of the diagnostic results Disabling the points under 6dN can be useful to ignore interfering data dominated by soft tissue compression Sport Tech recommends increasing the applied force to no more than 12dN to allay discomfort to the patient 4 10 6 How the test works By applying force to the lateral aspect of the elbow joint the medial joint space widens and confers a stretching force to the MUCL The extent of medial joint space widening is proportional to the remaining function of the MUCL For the diagnostic distinction between normal partial tear expressed as percentage remaining function and complete tear the relative positions of the counterbearing pressure actuator and wrist holding device as well as the elbow joint width are critical The latter has been assumed to average 47mm Any
80. rcentage of tear in an injured ligament or the percentage of regained function during rehabilitation The device is inexpensive portable and requires no X rays or other imaging modalities Using LIGMASTER a physician an athletic trainer a physical therapist or a clinical assistant can conduct an examination and arrive at a diagnosis in less than ten minutes LIGMASTER is versatile compared with other stress devices This one compact package can test all of the clinically important ligaments of the knee ankle elbow and shoulder LIGMASTER is very simple to operate and does not require special instruction beyond correctly positioning the patient and elementary computer skills Current office staff can perform the test and obtain the computerized data readout including the actual diagnosis of ligament damage after only minimal training LIGMASTER is fast An examination of the ankle knee elbow or shoulder ligaments takes only minutes and the diagnosis and data readout are promptly stored and printed out in clinical format LIGMASTER is safe The device is designed around the Telos stress device which has a long history of safe clinical use Also because LIGMASTER M requires no X rays all concerns about radiation exposure are eliminated The LIGMASTER M technique has been demonstrated to have a high degree of accuracy and reproducibility essential in providing diagnostic information In summary LIGMASTER M improves upo
81. ression of the soft tissues overlying the posterior aspect of the upper arm The linearity continues when the capsule ligaments of the shoulder joint kick in at higher force showing a steeper slope that is reduced proportional to the percentage capsular ligament tear relative to the comparison uninjured joint For complete tears of the gleno humeral ligaments and or the capsule the point of angulation between the two lines is well moved to the right on the screen Slack in the capsule ligaments can be quantified from the point of intersection of the second parts of the slopes with the x axis but considerable slack may be difficult to distinguish from complete tears Unlike ankle knee and elbow ligament injury shoulder capsule ligament tears have not been extensively examined by instrumented arthrometry at the time of writing this manual As a result there are at present no references available that can clinically validate the above criteria for interpreting the diagnostic data of shoulder stress exams However their similarity to the ACL stress exams provides some indication that the above criteria may well be correct See our website at www ligmaster com for updates on shoulder stress exams LigMaster User s Manual Sport Tech Inc Page 45 4 11 6 How the test works By applying force to the posterior aspect of the humerus with the counterbearings positioned anterior to the coracoid process and distal humerus respectively the head of th
82. result there are at present no references available that can clinically validate the above criteria for interpreting the diagnostic data of shoulder stress exams However their similarity to the ACL stress exams provide some indication that the above criteria may well be correct See our website at www ligmaster com for updates on shoulder stress exams 4 13 6 How the test works By applying force to the anterior aspect of the upper arm with the counterbearings positioned on the scapular spine and posterior aspect of the distal humerus respectively the head of the humerus is subluxed from the glenoid cavity while being restrained by the intact or remaining capsule ligaments The force subluxation relationship when plotted by LIGMASTER M is represented by a straight line once the preceding compression of the soft tissues of the upper arm has been accounted for For the determination of the percentage tear including complete tear only the applied forces and the resulting humeral head displacements enter into the calculations but not the positions of the counterbearings However these positions should be registered and recalled for any subsequent or comparison exam in order to validate diagnostic interpretation LigMaster User s Manual Sport Tech Inc Page 52 4 14 Ankle Lateral Ligaments The lateral ligaments of the ankle specifically the anterior talofibular ATF ligament and the calcaneofibular CF ligament are the most commonly i
83. s for patient anatomy will cause invalid results Acquire Advanced EX E peo P LigMaster User s Manual Sport Tech Inc Page 18 4 2 Selecting the comparison The next step is to select a comparison test Using a previous test as a comparison will speed up the setup somewhat as the settings for the stress device are usually constant from test to test for any particular patient Acquire Test Data x Select Comparison Test Select a comparison test if desired C Acquire a new comparison test Specify a previous test as a comparison Right Mar 07 2002 13 36 Knee ACL Left Mar O07 2002 13 3 lt Back Cancel LigMaster User s Manual Sport Tech Inc Page 19 4 3 Describing the test In the next dialog box you can provide the test with a title and save any comments Giving each test a meaningful title is helpful in keeping track of your patient s history You can edit this later if you wish Acquire Test Data l x Annotations Describe the test Patient Doe John Acquired Mar 10 2002 11 07 Title Comments 4 4 Positioning the patient and entering patient data The next step is to position the patient in the stress device and enter stress device settings The patient positioning and test dialog screens will be specific for the ligament under investigation In all of the tests you will find that consistent patient positioning is the key to getting highly
84. ster User s Manual Sport Tech Inc Page 8 instructions When installation is complete you will be able to start Adobe Acrobat Reader from your Windows START menu 2 3 Setting Up and Connecting the Stress Device The LIGMASTER stress device comes partially assembled in a hard shell carry case Instructions for assembling the hardware are included with the stress device The stress device consists of an adjustable frame a sliding pressure actuator and a number of different attachments which are used to position the patient for the evaluation of the various joints LIGMASTER uses a subset of the Telos GA II E stress components After unpacking the stress device make sure that the following system components are present Stress device Frame O rotary encoder Counterbearings USB Cable LigMaster User s Manual Sport Tech Inc Pressure Actuator EM Pressure head extension ul Ankle holder 80mm extension EM a EM E Wrist supports Wrist support Frame Page 9 To assemble the stress device first attach the pressure head to the stress device frame using the latching mechanism under the pressure head Then add additional attachments as needed The USB cable always plugs into a jack on the bottom right corner of pressure actuator faceplate The cable connectors are physically constructed so that the cable cannot be plugged in incorrectly The other end of the USB cable plugs
85. t for positioning the patient Once you have entered the numbers you must check the box on the right to verify the numbers LigMaster User s Manual Sport Tech Inc Page 54 Acquire Test Data x Readings Set device positions to the following ruler readings Set position A to 20 v Check when position set Set position B to 272 v Check when position set Set position C to 420 v Check when position set lt Back Cancel 4 14 4 Acquiring Joint Force response data Once you have entered and verified the patient positioning data you are ready to apply force to the joint and to collect data on the resulting joint response See section 4 4 on acquiring test data 4 14 5 Interpreting the diagnostic data The force strain data collected on screen in real time provide the key to the diagnostic interpretation of the test results See How does LIGMASTER work in section 10 3 The first part of the graph up to 6 dN force represents mostly elastic compression of lower leg musculature and the rubber components of the pressure plate counterbearing and ankle holder and does not provide any diagnostic information For this reason the first part of the graph has been disabled Therefore only the test data from 6 dN and upwards are shown on the screen Whether the comparison ankle is the normal opposite ankle or the pre injury same ankle the line for the comparison has been designed to go through the origin and
86. the comparison ankle LigMaster User s Manual Sport Tech Inc Page 53 For the majority of patients the side arms can be held in their extreme positions with A at 20 and C at 420 For patients with short legs or children it may be necessary to move the side arm closest to the knee inwards to ensure that the counterbearing touches the outer aspect of the leg below the knee joint The pressure actuator is positioned as shown in the illustration with the edge of the rubber padding on the pressure plate at the level of the most medial point on the medial malleolus If for small ankles the rubber padding on the pressure actuator is seen to interfere with the ankle holder it is expedient to reposition the pressure actuator more proximally by one or two centimeters Provided the same adjustment is made when examining the comparison ankle no effect on diagnostic outcome will result from this repositioning Lock the side arms and pressure actuator in position by the locking mechanisms oe gt m M LA as Figure 4 14 2 Left Ankle mounted in stress device for lateral exam 4 14 3 Entering positioning information in the LIGMASTER software Once you have positioned the patient in the stress device you must enter the positions of each side arm A and C and the pressure actuator B If the exam is based ona previous comparison the previous LIGMASTER settings will be recalled and can be used as a Starting poin
87. tlent iecit ee t e Ri cc botte n leek deena regem ae ede ied ra eed rented 15 3 2 S lectinga pallorem et pte ede i ect ee tet e Doce rc eras d tae d ee ed Ee Ede 16 4 Measuring Ligament TUDCETIOD eiii eite rte ot P ete a e i e Rape oe re ERR ER Cd 17 41 Selecting the testo cette te te e sect teu e le lane v tee eet ed Reid 17 4 2 Selecting the CompariSOn cii oi tte ciet deat e ed Le e arbe a P Eo pee ducts 19 4 3 Descrbing the tests eire ecc ee ite rite kis ette d eo rada bu ceto eve heme Ea RERO TREE E 20 4 4 Positioning the patient and entering patient data ssseeeeen enn 20 4 5 Acquiring Stress data uut eicere ten t ecce ie ei teda tu evt ee eee dore d Ee Eod 21 4 54 Manual Method icit ete e oerte une eter te dee t e ea tete aeBe coca 22 4 5 2 Auto Acquire Method ie tee eiecti Ue E teet 23 4 6 Knee AGE erc eta etc uiti ie detiene p tet o leta ee e er ree Ug Ae eed ERR Ee dca 24 4 6 1 Setting p the Stress device oi kc en aee eR i eed t bett ada 24 4 6 2 Positioning ING paien coetu ter citet eee eee eee atero eei re Vates Ucet ie ca 24 4 6 8 Entering positioning information in the LIGMASTER software ssssessee 25 4 6 4 Acquiring Joint Force response data sssessssssseeeneeenenenenenen nennen 26 4 6 5 Interpreting the diagnostic data cccceecccceeeecccceeeeeeeeeeeeeeceeeesaeeeeeseaeeesseeaeeeeeseaeeeseeeaeentees 26 LAM GrI duc c 27
88. to the ligaments equals F G a 1 o 1 where a is 1 l the ratio of the lengths of the stretched I and the unstretched l ligaments The proportionality factor G represents the equivalent elastic modulus and can be expressed as G RTANaq qu 2 Here R stands for the gas constant T the absolute temperature A the cross section of the unstretched ligament and Ng the number of moles of polymeric chain between crosslinks per unit of of dry ligament Crosslinks can be locations on the polymeric chain where three or more chains join together either by covalent electrostatic or even van der Waals type of bonding Also small crystalline regions in the otherwise amorphous polymer can act as crosslinks q V Vq represents the degree of swelling of the ligament which equals the ratio of the volume of the ligament and that of the dry ligament components qo is here the degree of swelling for the condition of the relaxed polymer chains when their spatial configuration is unaffected by interaction with the swelling agent Flory s theta condition In the clinical settting of ligament stressing all factors on the right side of equation 2 will remain constant except for q However any change in the degree of swelling of a swollen polymer network on stretching is quite small and diffusion controlled and can be conveniently ignored for the duration of the stress examination Therefore a plot of F against a 1 a is expected to prod
89. uce a straight line with a slope G LigMaster User s Manual Sport Tech Inc Page 71 proportional to the cross sectional area of the unstretched ligament as indeed has been found for ankle knee and elbow ligaments when examined clinically and when the excised ligaments were tested in our laboratories In the case of a partially torn ligament the cross sectional area will be proportinally reduced and with all other factors in equation 2 remaining constant so will G Therefore the extent of ligament tear can be determined from the decrease in the normal value for G This finding enables us to correlate decrease in ligament cross section or percentage partial tear of the ligament with extent of functional loss in terms of reduced values for the equivalent elastic modulus of the ligament For the case of a complete 100 tear tear of the ligament the ruptured ends are no longer connected and as a result a breakdown in visco elastic properties and loss of ligament function has been recorded The above premises have been thoroughly tested by stress examining patients prior to surgery and by stretching excised intact ligaments and partially severed ligaments in an Instron tensile testing machine The validity of equation 1 has been confirmed for ligament elongation up to 20 Values for G have been found to decrease linearly with percentage transection of the ligament extrapolating to zero for 10096 transection thereby demonstrating
90. ury for all ligaments amp LigMaster Doe John 10 x Patient Test View Tools Help Capsular Displacement mm 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 Doe John 154 AR 444 S Comparison g 12 Right Shoulder Anterior WO ox Tot f 7 2002 15 30 14 7 10 ht 9 1 A e Force dN ii 54 Right Shoulder Anterior w o ext rot T Mar 07 2002 15 29 34 94 14 a B oF E 0 15 mm 02 01 a 04 02 03 04 05 06 OF 08 09 1 11 12 43 A 15 46 Capsular Strain a 1 o LigMaster User s Manual Sport Tech Inc Page 13 2 4 4 Viewing the raw test data Physicians and scientists interested in clinical studies research papers etc may wish to see the raw force displacement and angle of rotation data that is used by LIGMASTER M This is accessible from the Test Select dialog box by hitting the Edit button amp LigMaster Doe John T Jin x Patient Test View Tools Help LigMaster Diagnostic Summary Capsular Displacement mm 6 2 D Zt 6 18 Z0 Z2 Z 26 Z8 3 mX 3 Patient name Doe John Doe John Last seen Thu Mar 07 13 10 14 2002 fe Test Right Shoulder Anterior w o ext rot ui Date Thu Mar 07 15 29 33 Bue select Test for Doe John xj Comparison Right Shoulder Ar d an Shoulder Posterior Left Mar 07 2002 15 36 Date Thu Mar 07 15 30 49 200 Shoulder Posterior Left Mar 07 2002 15 35 Comi Righi Shoulder Anterior wo exi rol Nex OF ZU 0530 A
91. very easy to add new patients and administer diagnostic tests for your patients 3 1 Adding a new patient The first step is to create a patient file for each new LIGMASTER patient This can be done during an exam or beforehand M LigMaster Doe John EN 3 nmj x P Patient Test View Tools Help er Diagnostic Summary Capsular Displacement mm 6 z 12 1 6 18 Z0 Z2 Z2 26 Z8 X x2 3 name Doe John uL Doe John n Thu Mar 07 13 10 14 2002 Test Right Shoulder Anterior w o ext rot NERIS 12 Date Thu Mar 07 15 29 33 2002 m Comparison Right Shoulder Anterior w o extrot Z Date Thu Mar 07 SSS lt NNN m Contact Information Test analysis Last ji initial x intercept _ Address 1 i initial slope 3 73 Fist Address 2 somes angulation at 1 13 ui Cees 3 final slope 22 1 ID State Comparison analys Zip Code initial slope 4 57 File Telephone angulation at 1 14 Last final slope 23 9 Vist Mar 10 2002 10 37 Now Characteristics 34 Comments Shoulder Anterior v The Test has more Sex Percentage Incre Age Weight Height From the File menu select New Patient which will open the Patient Information dialog box This dialog box allows you to enter relevant patient information LIGMASTER can help you keep track of patient information although you do not need to fill in all of the fields in
92. vide their own cable for custom installations Any length USB cable can be used although a good quality cable is recommended These are readily available from a number of vendors in lengths from 1 2 meter to 5 meters Extension cables are also available Caution Always use safe cabling practices Keep the USB cable away from moving equipment and make sure that it does not become a trip hazard 2 2 Installing the Software To install LIGMASTER insert the LIGMASTER M CD in the CD drive of your computer From the Windows START Menu select Run In the Run dialog box type the drive letter of your CD drive followed by setup e g e setup and follow the installation instructions When installation is complete you will be able to start LIGMASTER from your Windows START menu During installation you will be given the option to put a LIGMASTER icon on your desktop so that you can start LIGMASTER M from the desktop The LIGMASTER User Manual uses the Adobe Acrobat Reader to display all user documentation A copy of The Acrobat Reader installation program is included on the LIGMASTER installation disk If you do not already have the reader installed or wish to install a new version you may do so during LIGMASTER installation From the Windows START Menu select Run In the Run dialog box type the drive letter of your CD drive followed by adobesetup e g e adobesetup and follow the installation LigMa

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