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Knee ligament testing system    
United States Patent4583555   
Link to this pagehttp://www.wikipatents.com/4583555.html
Inventor(s)Malcom; Lawrence L. (San Diego, CA); Daniel; Dale M. (La Mesa, CA); Jamison; Conny M. (San Diego, CA); Landesman; Robert E. (Encinitas, CA)
AbstractA tibia-referenced system for objectively testing the integrity of the anterior and posterior cruciate ligaments of the knee with passive drawer, active drawer, and end point tests. Two simplified forms of the invention embody an elongated reference arm with a distal end pad that is fulcrumed against a distal region on the tibia and a proximal reference pad that rests on either the tibial tubricle or patellar bone structure, while a displacement indicator rod slidably mounted on the arm carries another proximal reference pad that rests on the other of these two bone structures adjacent the knee joint. In a third form of intermediate complexity, the second reference structure, instead of the indicator rod, is a second elongated reference arm distally pivotally connected to the other reference arm, each of the two arms carrying a reference pad that rests on a respective one of the tibial tubricle and pateller bone structures; and in this form the relative angular pivotal positions of the arms is translated to a displacement indicator dial that provides a direct readout of anterior or posterior drawer shift. The fourth and most complex form of the invention has the distally pivoted reference arms and direct readout displacement indicator dial of the third form, and further includes a case in which the arms are pivoted that is strapped against the tibia, with a force-applying handle extending anteriorly of the case and a force-indicating transducer operatively arranged between the handle and the case to audibly indicate predetermined applied force levels.
   














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Drawing from US Patent 4583555
Knee ligament testing system - US Patent 4583555 Drawing
Knee ligament testing system
Inventor     Malcom; Lawrence L. (San Diego, CA); Daniel; Dale M. (La Mesa, CA); Jamison; Conny M. (San Diego, CA); Landesman; Robert E. (Encinitas, CA)
Owner/Assignee     Medmetric Corporation (San Diego, CA)
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Publication Date     April 22, 1986
Application Number     06/455,248
PAIR File History     Application Data   Transaction History
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Litigation
Filing Date     January 3, 1983
US Classification     600/595
Int'l Classification     A61B 005/10
Examiner     Howell; Kyle L.
Assistant Examiner     Hanley; John C.
Attorney/Law Firm     Gabriel; Albert L.
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USPTO Field of Search     128/774 128/782 128/92 E 33/174 D
Patent Tags     knee ligament testing
   
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We claim:

1. A method of testing a cruciate knee ligament which comprises the steps of:

making a determination of first locations relative to each other, in the general anterior/posterior direction, of the tibial tubrical and patellar bone structures adjacent the knee joint of a leg by engaging first and second locating members directly against the anterior surface of the leg in registry with the tibial tubrical and patellar bone structures, respectively, and making a first comparison of the relative positions of said locating members in the general anterior/posterior direction;

while maintaining said engagement of said locating members against said leg, applying a force to the proximal tibia of said leg in the general anterior/posterior direction, with said patellar bone structure being restrained against movement, so as to relatively displace said bone structures from their said first relative locations to second locations relative to each other in the general anterior/posterior direction which will cause a corresponding relative displacement between said locating members; and

while said force is being applied making a determination of said second relative locations of said bone structures by making a second comparison of the relative positions of said locating members in the general anterior/posterior direction;

the difference between said second and first comparisons of the relative positions of said locating members indicating the amount of tibia/femur drawer shift at said knee joint.

2. The method of claim 1, which comprises:

performing said method steps relative to an injured knee joint of a person;

performing said method steps relative to an uninjured knee joint of said person; and

comparing the amount of said drawer shift of said injured knee joint with that of said uninjured knee joint.

3. The method of claim 1, wherein said force is directed generally anteriorly for testing the anterior cruciate ligament of said knee joint.

4. The method of claim 3, wherein said patellar bone structure is restrained against anterior movement by applying a posterior stabilization counterforce to said patellar bone structure.

5. The method of claim 3, wherein said leg is arranged with said knee joint at a flexion angle within the range of from approximately 20.degree. to approximately 30.degree..

6. The method of claim 5, wherein said knee joint is supported within said flexion angle range by means of a posterior thigh support platform.

7. The method of claim 6, wherein the rotational angle of the tibia of said leg is maintained substantially constant by means of a foot support platform which supports the foot of said leg against external rotation.

8. The method of claim 3, wherein said force is applied against the calf of said leg so as to perform a passive anterior drawer test.

9. The method of claim 3, wherein said force is applied by contraction of the quadriceps muscles of said leg to perform an active anterior drawer test.

10. The method of claim 1, wherein said force is directed generally posteriorly for testing the posterior cruciate ligament of said leg.

11. The method of claim 10, wherein said patellar bone structure is restrained against posterior movement by the femur of said leg.

12. The method of claim 10, wherein said leg is arranged with said knee joint at a flexion angle within the range of from approximately 70.degree. to approximately 90.degree..

13. The method of claim 10, wherein said force is applied against said tibial tubricle bone structure so as to perform a passive posterior drawer test.

14. The method of claim 1, wherein said tibial tubricle bone structure is initially displaced posteriorly relative to said patellar bone structure, and said force is directed generally anteriorly and applied by contraction of the quadriceps muscles of said leg to perform an active posterior drawer test.

15. The method of claim 1, wherein said force is applied at a predetermined, measured force level.

16. The method of claim 15, wherein said force level is approximately twenty pounds.

17. The method of claim 1, which comprises an "end point" test, wherein an initial force at a first predetermined force level is applied in the general anterior/posterior direction while determination of said first relative locations is made,

and said force that is applied while making said determination of said second relative location is at a second predetermined force level that is higher than said first force level.

18. The method of claim 17, wherein said first force level is approximately fifteen pounds and said second force level is approximately twenty pounds.
 Description Submit all comments and votes
 


BACKGROUND OF THE INVENTION

1. One Field of the Invention

The present invention is in the field of knee ligament testing systems, and it relates particularly to apparatus and methods for measuring anterior and posterior drawer shift or displacement of the proximal tibia relative to the distal femur as a result of applied forces so as to determine the presence or absence of a torn anterior or posterior cruciate ligament, respectively.

2. Description of the Prior Art

The clinical test which is the most similar to the method of the present invention for determining a disrupted or torn anterior cruciate ligament is known as the "Lachman" test. The Lachman test has been taught for many years by John W. Lachman, Chairman and Professor of Orthopedic Surgery at Temple University. The Lachman test is described in considerable detail by Torg, J. S., Conrad, W., and Kalen, V. in an article entitled "Clinical Diagnosis of Anterior Cruciate Ligament Instability in the Athlete", in The American Journal of Sports Medicine, Vol. 4, No. 2, March/April, 1976 at pages 84-93. In performing the Lachman test, the patient lies supine on a table with the knee held between full extension and 15.degree. of flexion. The person performing the test holds the thigh in one hand and the calf in the other, applying a firm anterior pressure to the calf in an attempt to translate the proximal tibia anteriorly relative to the distal femur. A positive test which indicates a torn or disrupted anterior cruciate ligament is one in which there is proprioceptive and/or visual anterior translation of the tibia in relation to the femur with a characteristic "mushy" or "soft" end point. This is in contrast to a definite "hard" end point elicited when the anterior cruciate ligament is intact.

The principal failing of the Lachman test is that it is entirely subjective and provides no measurement of knee displacement. Thus, the Lachman test provides no objective basis for comparison either with the sound knee of the patient or with statistical information relating the amount of displacement to the condition of the anterior cruciate ligament. The entirely subjective nature of the Lachman test also precludes its use in the development of any statistical information comparing anterior drawer shifts between uninjured and injured knees.

Another problem with the Lachman test is that the required grasping of the thigh and calf in the hands of the tester tends to cause patient guarding or resistance by muscular contraction, which will mask the true condition of the anterior cruciate ligament. The Lachman test is useless in the case of an acute knee injury (within seven days of the occurrence of the injury) when the knee joint is usually still swollen and painful, which greatly increases patient guarding. Further problems with the Lachman test are that a person with small hands has difficulty performing this test; and even with large hands the thigh and calf of an obese person cannot be adequately grasped to perform the test.

The first system capable of measuring or documenting the anterior or posterior displacement of the proximal tibia relative to the distal femur was that of J. C. Kennedy and P. J. Fowler, who described their system in an article entitled "Medial and Anterior Instability of the Knee. An Anatomical and Clinical Study Using Stress Machines," Journal of Bone and Joint Surgery, Vol. 53-A, 1971, at pages 1257-1270. According to the Kennedy ahd Fowler system, the patient was strapped upright into an immovable seat resembling a hydraulic barber's chair and the foot strapped down with the knee bent to 90.degree. of flexion. An anterior pulling force or a posterior pushing force was applied to the proximal tibia by gas-pressurized actuator cylinders. X-Rays were taken of the tibia and femur relative positions before and after the force was applied, and the displacements were recorded by directly measuring the motions seen on the X-Ray films. This system had the disadvantage that it had no direct mechanical means for indicating or measuring the tibial displacements relative to the femur as they occurred, as well as the inherent disadvantages of X-Rays. Another, major disadvantage of this system was that it attempted to immobilize the femur in what can be considered to be an earth-based or chair-based system. The problem with such reliance upon the supposed immobilization of the femur is that the femur is encased in a large amount of muscle tissue which, when relaxed as required for such testing, provides no firm locational support for the femur. On the other hand, if the muscles are tight enough for a somewhat rigid supporting of the femur, then the muscle tightness opposes the tibia/femur displacement which is the objective of the test.

A still further failing of the Kennedy and Fowler system was that their equipment was only capable of measuring knee displacements at 90.degree. of flexion. Applicant has found that while 90.degree. of flexion is sometimes satisfactory for posterior drawer testing, it is quite unsatisfactory for anterior drawer testing because of the large amount of posterior leverage which the powerful hamstring muscles have in opposition to the anterior drawer test, whereby only a slight amount of hamstring guarding will mask the anterior drawer test at large angles of knee flexion such as 90.degree.. This problem is not present in the Lachman anterior drawer test, wherein the knee is between full extension and 15.degree. of flexion.

In any earth-based or chair-based system such as that of Kennedy and Fowler, the imposing nature of the large and complex equipment, the discomfort of the apparatus employed to strap the patient down, and then the large amount of time, usually at least about 11/2 hours, required to strap the patient down, adjust the equipment and take the tests, inevitably caused patient guarding that interfered with the accuracy of the tests.

Markolf, K. L., Graff-Radford, A., and Amstutz, H. C., reported the fitst equipment that was capable of indicating or recording anterior/posterior tibial force versus displacement. This was reported in an article entitled "In Vivo Knee Stability", in the Journal of Bone and Joint Surgery, Vol. 60-A, No. 5, July, 1978, at pages 664-674. In this system a handle attached to a force transducer is strapped around the patient's calf. The examiner manually pulls or pushes through the handle which senses the force that is being applied as a displacement transducer records the displacement of the proximal tibia relative to the patella on the femur.

The Markolf et al system is again an earth- or chair-based system which has the same failings as those pointed out hereinabove for the Kennedy and Fowler system. In the Markolf et al system the reference point for all tibial displacement measurements is the chair, so that considerable equipment is directed toward an attempt to immobilize the patient's femur. Thus, there is a system of inflatable thigh compression pads, a contoured patellar compression block, and compression of the patient's sacrum by the rigid back of the chair. Additionally, the patient's foot is strapped down. As with the Kennedy and Fowler apparatus, the Markolf et al apparatus, due to its large, complex and imposing nature, the discomfort of the strapped-down patient, and the approximately 11/2 hours required to set up and perform the testing, caused considerable patient guarding that seriously interfered with the testing.

Applicant is aware of only one other type of apparatus which seeks to determine the presence or absence of a knee ligament deficit condition. This was reported by Crowninshield, R.; Pope, M. H., Johnson, R,; and Miller, R. in an article entitled "The Impedance of the Human Knee" in the Journal of Biomechanics, Vol. 9, 1976 at pages 529-535. This was laboratory apparatus which applied a cyclic rotational motion about the longitudinal axis of the tibia. By varying the frequency of the mechanical oscillation of the tibia while at the same time attempting to keep the femur relatively stable, the mechanical impedance characteristics of the knee were measured. These included the resonant frequency of oscillation of the knee, the change in the phase lag between the force input cycle and the displacement output cycle with varying frequency, and the like. Since the Crowninshield et al apparatus imposed only rotational or varus-valgus (medial and lateral bending) motions on the knee, this equipment was not capable of indicating or measuring anterior or posterior tibia/femur drawer shift to determine whether or not the anterior and posterior cruciate ligaments were torn.

A general failing in the art was the inability of any of the prior art systems to test the condition of anterior or posterior cruciate ligaments in the case of an acute knee injury, i.e., within seven days of the occurrence. This was primarily because of guarding that resulted either from hand manipulation that was required for the testing or from reaction to the discomfort of equipment used to strap down the patient's leg.

SUMMARY OF THE INVENTION

In view of these and other problems in the art, it is a general object of the present invention to provide a system for testing the condition of the anterior and posterior cruciate knee ligaments that provides an objective measurement of drawer shift or displacement between the proximal tibia and the distal femur quickly and easily, and with a minimum of discomfort to the patient.

Another object of the invention is to provide a system for testing the integrity of the anterior and posterior cruciate ligaments which, while providing an objective measurement of the tibia/femur displacement not possible with the Lachman test, nevertheless does not require that the patient be strapped down in a complicated chair arrangement attempting to immobilize the femur as in both the Kennedy et al and Markolf et al systems.

A principal object of the present invention is to provide, for the first time in this art, a tibia-referenced system for measuring anterior and posterior knee drawer shifts, as distinguished from the earth- or chair-based systems of Kennedy et al and Markolf et al; the tibia-reference system of the invention avoiding any necessity for strapping down the thigh in an attempt to immobilize the femur, and thereby enabling the thigh to rest in comfort during the testing and avoiding much of the prior art problem of patient guarding by contraction of quadriceps and/or hamstring muscles of the thigh.

A further object of the invention is to provide a knee ligament testing system which, by being a tibia-referenced system and thereby avoiding discomfort of the thigh and consequent patient guarding, for the first time enables testing for deficit conditions of the anterior and posterior cruciate ligaments in the case of an acute knee injury, i.e., within seven days of the occurrence of the injury, which can be a time of critical importance in the correction of a knee ligament deficit condition.

A further object of the invention is to provide a system for testing the integrity of the anterior and posterior cruciate ligaments of the knee which references the proximal end of the tibia and the distal end of the femur through respective accessible, generally unyielding anterior bone structures proximate the knee, namely, the tibial tubricle and the patella; this referencing through the tibial tubricle and the patella providing a much more reliable and accurate representation of the knee joint displacement than prior art earth- or chair-based systems, and avoiding the necessity for manually squeezing the area around the knee or putting the thumb on the joint line as were done in the Lachman test and which may be painful in an acutely injured patient.

A still further object of the invention is to provide a tibia-referenced knee ligament testing system with its accompanying increased accuracy and minimized patient guarding, wherein both the displacement measurement and the anterior and posterior forces applied during the testing are objective, whereby comparative test results between a patient's injured and uninjured knees or between an injured knee and statistical data representing either injured of uninjured knees, enables a reliable determination to be made as to whether or not there is a torn anterior or posterior cruciate ligament in the injured knee.

Four forms of the invention are disclosed herein, the first two being simplified forms, the third being a form of intermediate complexity but with a more directly readable tibia/femur displacement indicator, and the fourth being the most complex form disclosed and having both a direct displacement indicator and a force transducer that audibly indicates predetermined anterior- and posterior-directed force levels. Each of these four forms of the invention disclosed herein references two anterior bone structures closely adjacent to the knee joint, namely, the tibial tubricle forming a part of the tibia bone and the patella which overlies the femur bone, making use of the fact that the skin is very close to the anterior surfaces of both of these bone structures with minimal intervening flesh, so that the relative anterior/posterior locations of these bone structures accurately represents the relative anterior-posterior locations of the proximal tibia and distal femur.

In each of the four forms of the invention an elongated reference arm has a distal end that is oriented or fulcrumed against a distal region on the tibia, and has a proximal end that either rests on the tibial tubricle or on the patella; while a second reference structure that is movable relative to this reference arm rests against the other of these two anterior bone structures proximate the knee. Displacement indicator means operatively associated with these two reference structures indicates the relative positons of the proximal tibia and distal femur in the anterior-posterior direction.

In the first simplified form of the invention the reference arm has a distal reference pad which rests against a distal region on the tibia and a proximal reference pad which rests against the tibial tubricle, the arm extending proximally from the latter so as to overlie the patella. The second reference structure in this form of the invention is a displacement indicator rod slidably mounted near the proximal end of the reference arm, with a patella reference pad on the posterior end of the rod and a displacement indicator scale along the length of the rod and readable against the reference arm. The second simplified form of the invention is similar to the first simplified form, except that the proximal reference pad on the elongated reference arm is a patellar reference pad, and the displacement indicator rod has the tibial tubricle reference pad on its posterior end. With each of these two simplified forms of the invention for a passive anterior drawer test an anterior force is manually applied to the back of the calf under the tibial tubricle, while a posterior force is applied to the patellar reference pad to hold the patella securely against the femur and to prevent the femur from rising. A passive posterior drawer test is accomplished by manually applying a posterior force against the tibial tubrical reference pad. Thus, while the displacement indicator provides an objective reading of the displacement, nevertheless the force that is applied in testing with these two simplified forms of the invention is up to the feel and experience of the tester, and to that extent is subjective.

In the third form of the invention, which is of intermediate complexity, the second reference structure, instead of being a displacement indicator rod, is a second elongated reference arm that is pivotally connected to the other reference arm; i.e., in this form of the invention the two reference structures are a pair of distally pivotally connected reference arms. The shorter of these two arms is a tibial tubricle reference arm and is formed as a main case of the apparatus; while the longer of the two arms is a patellar reference arm. In this form of the invention the relative angular pivotal positions of the two reference arms is transduced to a displacement indicator dial that has a zeroing adjustment capability so that it can provide a direct readout of anterior or posterior drawer shift without requiring a difference calculation as is required in the two simplified forms of the invention. This third form of the invention still requires a hand-applied anterior force to the calf for a passive anterior drawer test, and a hand-applied posterior force to the tibial tubricle reference arm for a passive posterior drawer test, and is therefore subjective insofar as the amount of the applied force is concerned.

The fourth and most complex form of the invention disclosed herein, like the third form, has a pair of distally pivotally connected reference arms which respectively carry the tibial tubricle reference pad and the patellar reference pad. However, the two reference arms are pivotally connected at their common pivot axis to a case that is adapted to be strapped against the anterior surface of the tibia. A force-applying handle projects above or anterior to the case, and a force-indicating transducer is operatively arranged between the handle and the case to audibly indicate when specific predetermined force levels are applied either anteriorly to the calf under the tibia or posteriorly to the tibia, for making respective anterior and posterior drawer tests. As in the third form of intermediate complexity, the relative angular pivotal positions between the tibial and patellar reference arms is directly readable on a displacement indicator dial, so that with the addition of the force indicating transducer the fourth form of the invention is objective in all respects, including both displacement indicating and force indicating.

A novel posterior thigh support platform forming a part of the present invention is utilized with all four forms of the invention in making anterior drawer tests. This posterior thigh support platform automatically establishes the knee flexion angle within the preferred range of from approximately 20.degree. to approximately 30.degree., and allows the patient to relax both legs on a stable support surface, avoiding the necessity for the examiner to pick up and manually support the patient's knee, and thereby avoiding the difficulties that were encountered with the Lachman test with obese patients or large athletes, or if the examiner had small hands.

A novel foot positioning platform having both a horizontal footrest and upright lateral foot supports also forms a part of the present invention. This foot positioning platform supports both feet against external rotation, thereby keeping the starting rotational angle of the tibia the same in both knees for a more precise and reliable comparison of both knees with any of the four forms of the invention disclosed herein.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects and advantages of the invention will become more apparent from the following description taken in conjunction with the drawings, wherein:

FIG. 1 is a perspective view illustrating the first simplified form of the invention;

FIG. 2 is a side elevational view of the form of the invention shown in FIG. 1, operatively positioned upon a leg that is shown in sagittal section, with the posterior region of the thigh resting upon the raised posterior thigh support platform of the invention, and with the foot located on the foot support platform of the invention;

FIG. 3 is a view similar to FIG. 2, but with the second simplified form of the invention operatively positioned on the leg;

FIG. 4 is a perspective view illustrating the third form of the invention which is of intermediate complexity,

FIG. 5 is a horizontal section taken on the line 5--5 in FIG. 4;

FIG. 6 is a vertical section taken on the line 6--6 in FIG. 5 and illustrating the third form of the invention applied to a leg that is shown in saggital section;

FIG. 7 is a perspective view illustrating the fourth and most complex form of the invention disclosed herein;

FIG. 8 is a an enlarged, fragmentary top plan view of the form of the invention shown in FIG. 7, with the top section of the case removed from the bottom section of the case and turned over so that its underside faces upwardly;

FIG. 9 is a vertical section taken on the line 9--9 in FIG. 8;

FIG. 10 is a fragmentary vertical section taken on the line 10--10 in FIG. 8;

FIG. 11 is a fragmentary vertical section taken on the line 11--11 in FIG. 8;

FIG. 12 is fragmentary horizontal section taken on the line 12--12 in FIG. 11;

FIG. 13 is a diagrammatic view illustrating the electrical circuitry of the force transducer of the fourth form of the invention;

FIG. 14 is a side elevational view similar to FIGS. 2 and 3 but with the fourth form of the invention operatively positioned on the leg;

FIG. 15 is an enlarged, fragmentary side elevational view of the encircled region in FIG. 14 showing the joint line reference arrow;

FIG. 16 is a fragmentary saggital section of the knee joint at 90.degree. of flexion showing the location of the posterior cruciate ligament;

FIG. 17 is a view similar to FIG. 16, but with the knee at a flexion angle of 25.degree., illustrating the location of the anterior cruciate ligament;

FIG. 18 is a graph illustrating the passive anterior drawer test and compliance or end point test differences between an average normal knee and an average knee with a torn anterior cruciate ligament;

FIG. 19 is a fragmentary saggital section with the knee at approximately 25.degree. of flexion in preparation for an active anterior drawer test, but prior to contraction of the quadriceps muscles;

FIG. 20 is a view similar to FIG. 19, but with the quadriceps muscles contracted;

FIG. 21 is a fragmentary saggital section with the knee joint at a neutral flexion angle of from about 70.degree. to about 90.degree. for an active posterior drawer test, FIG. 21 showing the tibia/femur relative positioning either for a normal knee or with the quadriceps contracted;

FIG. 22 is a view similar to FIG. 21, but for a knee with a torn posterior cruciate ligament and with the quadriceps relaxed;

FIG. 23 graphically illustrates statistical information for the passive anterior drawer difference between normal knees and known anterior cruciate deficit knees;

FIG. 24 is a view similar to FIG. 23, but illustrating the active anterior drawer difference between normal knees and knees having a known anterior cruciate ligament deficit; and

FIG. 25 is a view similar to FIGS. 23 and 24 but illustrating the anterior end point laxity between 15 and 20 pounds of anterior force for normal knees and for knees having a known anterior cruciate ligament deficit.

DETAILED DESCRIPTION

FIGS. 1 and 2 illustrate one simplified tibia-referenced knee testing device according to the invention, and FIG. 3 shows another. Each of these two simplified forms of the invention embodies a single reference arm, and both of these forms are adapted for direct hand application of the anterior or forward testing force to the calf behind the tibial tubricle.

The first simplified form of the invention shown in FIGS. 1 and 2 is generally designated 10, and its principal structural element is an elongated, generally flat and preferably straight reference arm 12. The reference arm 12 has distal tibial end 14 and femoral end 15. For clarity and convenience in the following description, the reference arm 12 will also be designated as having an upper or anterior surface 16 and a lower or posterior surface 17.

Projecting downwardly from the reference arm 12 proximate its distal tibial end 14 is a distal tibial reference pad 18, the lower surface of which constitutes the distal tibial reference surface 20 of the device 10. Referencing of the device 10 to the tibia is completed by means of a proximal tibial reference pad 22 that projects downwardly from reference arm 12 at a location spaced proximally from the distal tibial reference pad 18 and located closer to the femoral end 15 than the distal tibial end 14 of reference arm 12. The bottom surface of proximal tibial reference pad 22 constitutes the proximal tibial reference surface 24 of the device 10. The two tibial reference pads 18 and 22 preferably project downwardly at right angles from the main body of the reference arm 12.

Relative positioning and displacement between the tibia and the femur in the anterior-posterior direction is indicated on a displacement indicator rod 26 that is slideably mounted in a bore 28 extending in the anterior-posterior direction through reference arm 12 preferably at right angles to the arm 12. Mounted on the lower end of indicator rod 26 is a patellar reference pad 30, the bottom surface 32 of which constitutes the patellar reference surface of the knee testing device 10. Actually, the reference pad 30 and its bottom reference surface 32 are for the purpose of referencing the anterior-posterior location of the distal end of the femur; however, the reference pad 30 and its reference surface 32 perform such femoral referencing through the patella which is the only stable, generally unyielding structure proximate the knee that is accessible for referencing the location of the distal end of the femur. Displacement indicator rod 26 and proximal tibial reference pad 22 are spaced apart longitudinally along the reference arm 12 a distance approximating the average spacing between patella 52 and tibial tubricle 50.

The displacement indicator rod 26 has an indicator scale 34 longitudinally arranged thereon which is adapted to be read at the upper surface 16 of reference arm 12. A knob 36 is mounted on the upper end of displacement indicator rod 26 for receiving a posteriorly directed stabilization counterforce during a passive anterior drawer test.

FIG. 2 shows the knee testing device 10 operatively positioned on a leg for performing the passive anterior drawer test. The leg is diagramatically illustrated, with the knee joint 38 shown generally in sagittal section. The leg is supported for this passive anterior drawer test with the knee joint 38 bent or flexed to a preferred flexion angle in the range of from about 20.degree. to about 30.degree. of flexion, and preferably at approximately 25.degree. of flexion, to minimize interference by ligaments and other knee components not involved in the test, and by hamstring guarding, as described more in detail hereinafter. This knee joint flexion angle represents angular displacement between the general longitudinal axes of the tibia 40 and femur 42 from the fully extended condition of the leg, the tibia 40 being the anterior and larger of the two long bones of the calf 44, and the femur 42 being the single long bone extending through the thigh 46.

The knee testing device 10 is placed against the anterior surface of the leg with the reference arm 12 arranged generally parallel to the tibia 40, the distal tibial reference surface 20 engaged at a distal region 48 of the tibia, the proximal tibial reference surface 24 engaged at the tibial tubricle 50, and the patellar reference surface 32 engaged at the patella 52. The patella 52 serves as a bearing for force applied by the quadraceps muscles 54 against the distal end of the femur 42, the quadraceps 54 all coming in and attaching to the patella 52 and thence through the patella 52 and the patellar tendon 56 (which is really a ligament) to the tibial tubricle 50. An anatomical factor in knee functioning which enables the present invention in all of its forms to be basically tibia referenced while also referencing to the patella is the fact that the patella slides distally and posteriorly on the curved lower end of the femur so that the patella is fully exposed on the femur in the general anterior direction of the tibia at any knee flexion angle up to and even beyond 90.degree. of flexion. Thus, the patella 52 is exposed as a reference point for anterior drawer tests with flexion angles ranging from about 20.degree. to about 30.degree. and also for posterior drawer tests with flexion angles ranging from about 70.degree. to about 90.degree..

To perform the passive anterior drawer test as illustrated in FIG. 2, the patient is preferably fully supported from head to foot on a firm horizontal surface 57. The knee joint 38 is stabilized for the test by placement of a raised posterior thigh support platform 58 under the thighs proximal to the patient's patella 52. Further stabilization of the knee joint 38 is accomplished by means of a foot support platform 60 which has a horizontal foot rest 62 preferably covered with foam rubber or neoprene and a pair of upright lateral foot supports 64 at opposite sides of the platform 60. The raised posterior thigh support platform 58 automatically establishes the desired knee flexion angle within the preferred range of about 20.degree. to 30.degree., and keeps this knee flexion angle constant throughout the test for accuracy of measurement. The foot support platform 60 supports the foot against external rotation which might otherwise interfere with the reliability and repeatability of the tests. Since most tests utilizing the present invention involve a comparison of the tibia-femur displacement of the injured knee with that of the uninjured knee, both of the thighs are supported on the raised thigh support platform 58 and both of the feet are supported by the foot support platform 60.

The tibia 40 provides an almost ideal base or referencing structure for the tibia-referenced system of the invention because the skin 66 is very close to the anterior surface of tibia 40, both in the distal region 48 thereof and at the tibial tubricle 50, with minimal intervening flesh.

To perform a passive anterior drawer test, the knee testing device 10 is operatively positioned as shown in FIG. 2 and the reading on displacement indicator scale 34 is noted and preferably recorded. An anterior-directed testing force is then applied, preferably with the right (or dominant) hand, to the back of the calf 44 behind tibial tubricle 50 as indicated by the arrow 70. As discussed in detail hereinafter, this anterior-directed force 70 is preferably about 20 pounds of force; however, since the simplified form 10 of the invention does not embody any force indicating means, the amount of this force will be up to the feel and experience of the tester, and therefore will be somewhat subjective. During this application of the anterior force 70, a posterior-directed stabilization counterforce is applied to the top of the force knob 36 as indicated by the arrow 72 to keep the entire knee and thigh firmly against the posterior thigh support platform 58, thereby blocking the tendency of the leg to lift off of the thigh support platform 58 during the test, which would cause the knee joint to flex and introduce an error in the measurement. The displacement indicator scale 34 is again read and preferably recorded while the force 70 and counterforce 72 are applied, and the difference between these two indicator scale readings will constitute a measurement of the anterior drawer shift or displacement of the tibial tubricle 50 relative to the patella 52, and hence relative to the distal end of femur 42. Preferably, the readout on displacement indicator scale 34 is directly in millimeters of anterior drawer shift or displacement at the knee joint line. Because the length from the fulcrum of distal tibial reference pad 18 to displacement indicator rod 26 is approximately 10 percent greater than the length from pad 18 to the knee joint line, the actual scale of displacement indicator scale 34 is expanded by approximately 10 percent from a true metric scale to give this direct readout in millimeters of drawer shift.

Accuracy of this anterior drawer test made with the knee testing device 10 may be slightly improved by applying the posterior stabilization force 72 and taking the first reading on the displacement indicator scale 34 prior to application of the anterior force 70. This causes the patellar reference pad 30 to seat firmly upon the skin 66 overlying the patella 52 and assures that the patella 52 is firmly seated in the femoral notch; otherwise, such seatings might occur between the two displacement indicator scale readings and introduce an error in the reading.

The passive anterior drawer test is for the purpose of testing the laxity of the anterior cruciate ligament. Referring to FIG. 17 of the drawings, the anterior cruciate ligament is generally designated 74, and its position in the knee joint 38 is illustrated for a knee flexion angle of 25.degree., which is the preferred testing angle for the anterior drawer test. It will be seen that the anterior cruciate ligament 74 comes from the posterior notch of the femur 42 and runs to the anterior plateau of the tibia 40. The anterior cruciate ligament 74 resists the tendency of the tibia 40 to slide forwardly relative to the femur 42. Cartilage surfaces at the ends of the tibia 40 and femur 42 are generally designated 76.

FIG. 16 shows the posterior cruciate ligament, generally designated 78, with the knee joint 38 at 90.degree. of flexion, which is the preferred knee flexion for performing a posterior drawer test. Such test will be described later. It will be seen that the posterior cruciate ligament 78 comes out of the distal end of the femur 42 and runs posterior to the tibia 40. The posterior cruciate ligament 78 mechanically functions as one of the stabilizers resisting posterior displacement of the tibia 40 relative to the femur 42.

The other cruciate ligament is not shown in each of the illustrations in FIGS. 16 and 7 for clarity of illustration.

Referring now to FIG. 3 of the drawings, the second simplified form of the invention is generally designated 10a, and it has as its principal structural element an elongated and preferably generally flat reference arm 12a having distal tibial end 14a, femoral end 15a, upper or anterior surface 16a, and lower or posterior surface 17a. The distal tibial reference pad 18a is the same as the reference pad 18 of the first form 10 shown in FIGS. 1 and 2, extending downwardly or posteriorly from the distal tibial end 14a of reference arm 12a preferably at right angles to arm 12a. The bottom surface of distal tibial reference pad 18a constitutes the distal tibial reference surface 20a of the device 10a.

Integral with the reference arm 12a and projecting downwardly from its femoral end 15a preferably at right angles to arm 12a is the patellar reference pad 30a, the bottom surface of which constitutes the patellar reference surface 32a of the device 10a. Thus, the reference arm 12a directly references the anterior-posterior locations of the distal region 48 of tibia 40 and the patella 52; whereas the reference arm 12 of the device 10 of FIGS. 1 and 2 directly references the distal region 48 of tibia 40 and the tibial tubricle 50.

In the knee testing device 10a of FIG. 3, the proximal tibial reference pad 22a, the lower surface of which is the proximal tibial reference surface 24a, is mounted or formed integrally on the lower end of the displacement indicator rod 26a which is slideably mounted in a suitable bore (not shown) through arm 12a for sliding movement in the anterior-posterior direction. Preferably, the rod 26a has its longitudinal axis directed at right angles to the arm 12a. The displacement indicator rod 26a is spaced longitudinally along the reference arm 12a from patellar reference pad 30a a distance approximating the average spacing between tibial tubricle 50 and patella 52.

The knee testing device 10a is operatively positioned as illustrated in FIG. 3, with the distal tibial reference surface 20a against the skin at the distal region 48 of the tibia, the patellar reference surface 32a against the skin at the patella 52, and the proximal tibial reference surface 24a against the skin at the tibial tubricle 50. With the device 10a thus located, the displacement indicator scale 34a on rod 26a is read and preferably recorded. Then, the anterior-directed displacement force indicated by the arrow 70a is applied to the back of calf 44, preferably with the right (or dominant) hand of the tester, while the posterior-directed stabilization counterforce indicated by the arrow 72a is applied to reference arm 12a proximate the patellar reference pad 30a with the left (or non-dominant) hand of the tester. While these forces 70a and 72a are being applied, the displacement indicator scale 34a is again read relative to the upper surface 16a of arm 12a, and this reading preferably recorded, and the difference between the two readings on indicator scale 34a will directly provide the amount of anterior drawer shift or displacement of tibia 40 relative to patella 52 and hence the distal end of femur 42, in millimeters of displacement. Because the length from the fulcrum of distal tibial reference pad 18a to displacement indi