Aetna considers knee ligament arthrometer testing experimental and investigational for evaluating ligament laxity in the knee or for other indications because the peer-reviewed medical literature does not support the clinical value of this testing.Background
There are a number of commercially available knee arthrometers. These devices provide computerized measurements of knee laxity. Knee ligament arthrometer testing can not replace the need for a physical examination and/or magnetic resonance imaging (MRI).
According to the manufacturer of one of the commercially available arthrometers, the KT1000™ (MEDmetric® Corporation, San Diego, CA) was developed to provide objective measurement of the sagittal plane motions of the tibia relative to the femur. This motion, sometimes referred to as drawer motion, occurs when an examiner applies force to the lower limb or when the muscles of the quadriceps are contracted. Although the KT1000 (or KT2000) and other knee ligament arthrometers have been employed for research purposes for quantifying outcomes of anterior cruciate ligament reconstruction, the peer-reviewed medical literature does not support its reliability, reproducibility, and clinical utility in the general clinical setting.
Spindler et al (2004) performed a evidence-based systematic review of randomized controlled trials assessing patellar tendon versus hamstring tendon autografts. Objective and subjective outcome measures included surgical technique, rehabilitation, instrumented laxity, isokinetic strength, patello-femoral pain, return to pre-injury activity, as well as Tegner, Lysholm, Cincinnati, and International Knee Documentation Committee-1991 scores. Slight increased laxity on arthrometer testing was observed in the hamstring population in 3 of 7 studies. Pain with kneeling was greater for the patellar tendon population in 4 of 4 studies. Only 1 of 9 studies reported increased anterior knee pain in the patellar tendon group. Frequency of additional surgery seemed to be related to the fixation method and not graft type. No study showed a significant difference in graft failure between patellar tendon and hamstring tendon autografts. Objective differences (e.g., range of motion, isokinetic strength, arthrometer testing) were not detected between groups in the majority of studies, suggesting that their sensitivity to detect clinical outcomes may be limited.
Papannagari et al (2006) stated that recent follow-up studies have reported a high incidence of joint degeneration in patients with anterior cruciate ligament (ACL) reconstruction. Abnormal kinematics after ACL reconstruction have been thought to contribute to the degeneration. These investigators hypothesized that ACL reconstruction, which was designed to restore anterior knee laxity under anterior tibial loads, does not reproduce knee kinematics under in-vivo physiological loading conditions. In a controlled laboratory study, these researchers examined both knees of 7 patients with complete unilateral rupture of the ACL with magnetic resonance image, and constructed 3D models from these images. The ACL of the injured knee was arthroscopically reconstructed using a bone-patellar tendon-bone autograft. Three months after surgery, the kinematics of the intact contralateral and reconstructed knees were measured using a dual-orthogonal fluoroscopic system while the subjects performed a single-legged weight-bearing lunge. The anterior laxity of both knees was measured using a KT-1000 arthrometer. The anterior laxity of the reconstructed knee as measured with the arthrometer was similar to that of the intact contralateral knee. However, under weight-bearing conditions, there was a statistically significant increase in anterior translation of the reconstructed knee compared with the intact knee at full extension (approximately 2.9 mm) and 15 degrees (approximately 2.2 mm) of flexion. Furthermore, there was a mean increase in external tibial rotation of the ACL-reconstructed knee beyond 30 degrees of flexion (approximately 2 degrees at 30 degrees of flexion), although no statistical significance was detected. The authors concluded that the data showed that although anterior laxity was restored during KT-1000 arthrometer testing, ACL reconstruction did not restore normal knee kinematics under weight-bearing loading conditions.
Wiertsema et al (2008) examined the reliability of the KT1000 arthrometer and the Lachman test in patients with an ACL rupture. A total of 20 patients with a complete tear of the ACL were examined in a single session each. During the assessment, 2 physical therapists measured the anterior-posterior translation of the knee using both the KT1000 arthrometer and the Lachman test. One examiner performed a repeated measurement of each test for determination of intra-rater reliability. The examiners were blinded to the findings of their colleague. The intraclass correlation coefficient (ICC) was used to describe the degree of reliability of the measurements. High ICCs were found for the intra-rater reliability and the inter-rater reliability of the Lachman test (ICC = 1.0 and 0.77). For the KT1000 arthrometer both ICCs were clearly lower (ICC = 0.47 and 0.14). The KT1000 arthrometer showed inadequate reliabilities, even when measurements are repeated within a single measurement session. Contrastingly, the Lachman test is a reliable measurement to determine the anterior-posterior laxity of the ACL deficit knee. The results of the present study suggested good within-session intra-rater reliability as well as inter-rater reliability for the Lachman test.
An UpToDate review on “Anterior cruciate ligament injury” (Friedberg, 2013) states that “The KT-1000 knee ligament arthrometer is a device that provides an objective measurement of anterior-posterior translation and is often used in studies evaluating ACL tears. This machine is seldom used in clinical practice because physical examination is generally reliable. Due to the high sensitivity of the Lachman and the high specificity of the pivot shift, we suggest performing both tests to confirm an ACL rupture. The combination of a positive Lachman and a negative pivot shift can mean the ACL is partially torn”.
Lustig and colleagues (2012) noted that the KneeKG™ system was developed with the objective of providing high reliability movement analysis. These researchers reviewed the technical details, clinical evidence, and potential applications of this system for evaluation of rotational knee laxity. A comprehensive review of the MEDLINE database was carried out to identify all clinical and biomechanical studies related to KneeKG™ system. The KneeKG™ system non-invasively quantifies knee abduction/adduction, axial rotation, and relative translation of the tibia and femur. The average accuracy of the acquisition is 0.4° for abduction/adduction, 2.3° for axial rotation, 2.4 mm for antero-posterior translation, and 1.1 mm for axial translation. This clinical tool enables an accurate and objective assessment of the tri-planar function of the knee joint. The measured biomechanical parameters are sensitive to changes in gait due to knee osteoarthritis and ACL deficiency. The authors concluded that the KneeKG™ system provided reliable movement analysis. They stated that this system has the potential to improve understanding the biomechanical consequences of trauma or degenerative changes of the knee as well as more accurately quantify rotational laxity as detected by a positive pivot-shift test.
Lorbach et al (2012) summarized the development of a simple, objective, and non-invasive measurement device, the Rotameter, for tibio-femoral rotation to assess static rotational knee laxity. The device is based on the dial test with the patient lying prone and the knee flexed to 30°. From measurements of 30 healthy participants, the device achieved high inter- and intra-observer reliability and showed a high correlation of the measured results with the contralateral knees of the participants. Measurements of the device were also performed in a human cadaver study and revealed highly correlated results when compared to the simultaneous measurements of a knee navigation system, which was used as an invasive standard method to assess tibial rotation. In human cadaver specimens, it was shown that a simulated tear of the postero-lateral bundle as well as a complete ACL tear led to a significant increase in isolated tibio-femoral rotation compared to the intact ACL. A retrospective case series investigated the clinical results as well as knee laxity measurements after ACL surgery in-vivo. Rotational, as well as antero-posterior, knee laxity was objectively assessed in 52 patients at a mean post-operative follow-up of 27 months by comparing the measured results with the results of the contralateral unaffected knee in each patient. The clinical results were comparable to the results reported in the literature. Moreover, rotational laxity was successfully restored after ACL reconstruction, whereas AP laxity showed significant differences compared to the contralateral knees although they were defined as clinically successful according to the IKDC classification. The authors concluded that a non-invasive and objective knee rotational measurement device has been developed, which offers good potential for objective quality control in knee ligament injuries and their treatment.
Mouton et al (2012) evaluated the influence of individual characteristics on rotational knee laxity in healthy participants and examined if the contralateral knee of patients with a non-contact ACL injury presents greater rotational knee laxity than a healthy control group. A total of 60 healthy participants and 23 patients having sustained a non-contact ACL injury were tested with a new Rotameter prototype applying torques up to 10 Nm. Multiple linear regressions were performed to investigate the influence of gender, age, height and body mass on rotational knee laxity and to establish normative references for a set of variables related to rotational knee laxity. Multiple analyses of co-variance were performed to compare the contralateral knee of ACL-injured patients and healthy participants. Being a woman was associated with a significantly (p < 0.05) higher rotational knee laxity, and increased body mass was related to lower laxity results. In the multiple analyses of co-variance, gender and body mass were also frequently associated with rotational knee laxity. When controlling for these variables, there were no differences in measurements between the contralateral leg of patients and healthy participants. The authors concluded that in the present setting, gender and body mass significantly influenced rotational knee laxity. Furthermore, based on these preliminary results, patients with non-contact ACL injuries do not seem to have excessive rotational knee laxity.
Ahlden et al (2012) stated that studies have reported that knee kinematics and rotational laxity are not restored to native levels following traditional ACL reconstruction. This has led to the development of anatomic ACL reconstruction, which aims to restore native knee kinematics and long-term knee health by replicating normal anatomy as much as possible. These researchers reviewed current dynamic knee laxity measurement devices with the purpose of investigating the significance of dynamic laxity measurement of the knee; gait analysis was not included. The subject was discussed with experts in the field in order to perform a level V review. MEDLINE was searched according to the discussions for relevant articles using multiple different search terms. All found abstracts were read and scanned for relevance to the subject. The reference lists of the relevant articles were searched for additional articles related to the subject. There are a variety of techniques reported to measure dynamic laxity of the knee. Technical development of methods is one important part toward better understanding of knee kinematics. Validation of devices has shown to be difficult due to the lack of gold standard. Different studies used various methods to examine different components of dynamic laxity, which makes comparisons between studies challenging. The authors concluded that several devices can be used to evaluate dynamic laxity of the knee. At the present time, the devices are continuously under development. Moreover, they stated that future implementation should include primary basic research, including validation and reliability testing, as well as part of individualized surgery and clinical follow-up.
Barcellona et al (2013) stated that the KT1000 and KT2000 knee joint arthrometers (MEDmetric Corp, San Diego, CA) have been shown to over-estimate the measurement of knee joint sagittal laxity. These investigators examined the accuracy of the KT arthrometers as measures of anterior and posterior linear displacement. The anterior and posterior linear displacements of 3 KT arthrometers (2 KT1000 arthrometers and 1 KT2000 arthrometer) were compared with the simultaneous displacement measured by a precision linear Vernier Dial Test Indicator (Davenport Ltd, London, U.K.). The displacement calculated using the analog output of the KT2000 was also compared with the values on the KT2000 displacement dial. Compared with the Vernier Dial Test Indicator, the KT arthrometers over-estimated anterior linear displacement by between 22 % and 24 %. True anterior displacement for all 3 arthrometers, as recorded by the Vernier Dial Test Indicator, was found by multiplying the KT value by 0.79. When compared with the Vernier Dial Test Indicator, the KT arthrometers under-estimated posterior linear displacement by between 18 % and 19 %. True posterior displacement, as recorded by the Vernier Dial Test Indicator, was found by multiplying the KT1000 value by 1.17 and the KT2000 value by 1.16. The authors concluded that the internal apparatus of the KT2000 and KT1000 knee joint arthrometers over-estimated anterior displacement and under-estimated posterior displacement with a predictable relative systematic error. Moreover, they stated that future validation studies should use these correction equations to assess the accuracy of the KT arthrometers; and sagittal plane knee laxity measured with the KT devices requires systematic correction for optimal accuracy.
Vauhnik et al (2013) evaluated the inter-rater reliability of the GNRB® knee arthrometer. Knee anterior laxity in both knees was tested in a group of young, uninjured subjects (n = 27, 13 females) by 2 examiners. Knee anterior laxity was calculated at test forces of 134N and 250N with values presented for the unstandardized and standardized conditions (relative to patellar stabilization force). The ICCs ranged from 0.220 to 0.424. The authors concluded that the inter-rater reliability of the GNRB® knee arthrometer is low.
Jang and colleagues (2014) determined objective factors involved in returning to sports following ACL reconstruction. Based on the inclusion criteria of a minimum 2-year follow-up, pre-injury sports activity level of Tegner 5 or greater, these researchers retrospectively evaluated 67 patients who underwent ACL reconstruction. The patients were divided into "return-to-sports" (n = 51) and "non-return" groups (n = 16) by surveying participants using a questionnaire. Comparisons between the 2 groups were made using pre-operative and post-operative International Knee Documentation Committee questionnaires (IKDC), Lysholm score, and KT-2000 arthrometer. Flexor and extensor muscle strength, and functional performance tests (1-leg-hop test, co-contraction, shuttle run, and carioca tests) were used for assessment. Overall clinical results, including IKDC score, Lysholm score, and KT-2000 arthrometer, improved in all patients post-operatively and no significant difference was seen between the 2 groups (p > 0.05). Although there was no significant difference in flexor or extensor deficits, 1-leg-hop test, or shuttle run test, "return-to-sports" group obtained significantly better scores in the co-contraction and carioca tests (p < 0.05). The authors concluded that tests that assess rotational stability showed statistically significant differences between the 2 groups. Moreover, they stated that further prospective studies with larger cohort are needed to determine the factors associated with returning to sports after ACL reconstruction.
|CPT Codes / HCPCS Codes / ICD-9 Codes|
|There are no specific codes for knee ligament arthrometer testing:|
|CPT codes not covered for indications listed in the CPB:|
|95851||Range of motion measurements and report (separate procedure); each extremity (excluding hand) or each trunk section (spine)|
|97750||Physical performance test or measurement (e.g., musculoskeletal, functional capacity), with written report, each 15 minutes|
|Other CPT codes related to the CPB:|
|27405||Repair, primary, torn ligament and/or capsule, knee; collateral|
|27409||collateral and cruciate ligaments|
|27427||Ligamentous reconstruction (augmentation), knee; extra-articular|
|27429||intra-articular (open) and extra-articular|
|29888||Arthroscopically aided anterior cruciate ligament repair/augmentation or reconstruction|
|29889||Arthroscopically aided posterior cruciate ligament repair/augmentation or reconstruction|
|ICD-9 codes covered if selection criteria are met:|
|717.81||Old disruption of lateral collateral ligament|
|717.82||Old disruption of medial collateral ligament|
|717.83||Old disruption of anterior cruciate ligament|
|717.84||Old disruption of posterior cruciate ligament|
|717.85||Old disruption of other ligaments of knee|
|717.89||Other internal derangement of knee|
|728.4||Laxity of ligament|
|844.0||Sprain and strain of lateral collateral ligament of knee|
|844.1||Sprain and strain of medial collateral ligament of knee|
|844.2||Sprain and strain of cruciate ligament of knee|
|844.3||Sprain and strain of tibiofibular (joint) (ligament), superior|