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The Stability study: a protocol for a multicenter randomized clinical trial comparing anterior cruciate ligament reconstruction with and without Lateral Extra-articular Tenodesis in individuals who are at high risk of graft failure.

ABSTRACT: BACKGROUND:The purpose of anterior cruciate ligament reconstruction (ACLR) is to restore stability to the knee. Persistent rotational laxity following ACLR has been correlated with poor outcome and graft failure. We hypothesize that anterolateral complex reconstruction by way of a Modified Lemaire Lateral Extra-articular Tenodesis (LET) in combination with single bundle ACLR would reduce the risk of persistent rotatory laxity in young individuals who are deemed as being at high risk of failure. We will conduct a pragmatic, multicenter, randomized clinical trial comparing standard single bundle hamstring ACLR with combined ACLR and LET. METHODS:Six-hundred patients (300 per group) aged 25?years or less with an ACL deficient knee that meet two of the following three criteria will be included: 1) Grade 2 pivot shift or greater; 2) Returning to high risk cutting or pivoting sports; 3) Generalized ligamentous laxity. Participants will be seen at 3-months, 6-months, 12-months and 24-months post-operatively. The primary outcome measure is graft failure requiring revision ACLR or symptomatic instability associated with a positive asymmetric pivot shift indicating persistent rotational laxity. Patients will complete secondary outcome measures at each follow-up visit including patient-reported outcome measures, functional and biomechanical testing, and magnetic resonance imaging. DISCUSSION:This protocol is the first adequately powered randomized clinical trial investigating the effects of augmenting ACLR with an LET in patients at high-risk of graft failure. The successful completion of this trial has the potential to change surgical practice and provide evidence for the role of the LET in ACLR. TRIAL REGISTRATION:The trial is registered at ClinicalTrials.gov: NCT02018354 , 23-12-2013.

SUBMITTER: Getgood A

PROVIDER: S-EPMC6521537 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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The Stability study: a protocol for a multicenter randomized clinical trial comparing anterior cruciate ligament reconstruction with and without Lateral Extra-articular Tenodesis in individuals who are at high risk of graft failure.

Getgood Alan A Bryant Dianne D Firth Andrew A

BMC musculoskeletal disorders 20190515 1

<h4>Background</h4>The purpose of anterior cruciate ligament reconstruction (ACLR) is to restore stability to the knee. Persistent rotational laxity following ACLR has been correlated with poor outcome and graft failure. We hypothesize that anterolateral complex reconstruction by way of a Modified Lemaire Lateral Extra-articular Tenodesis (LET) in combination with single bundle ACLR would reduce the risk of persistent rotatory laxity in young individuals who are deemed as being at high risk of f ...[more]

PMID: 31092226

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Project description:BackgroundIt is still controversial whether the combination of anterior cruciate ligament (ACL) reconstruction and extra-articular reconstruction (EAR) have good clinical efficacy. This meta-analysis aims systematically to compare the clinical effectiveness of ACL reconstruction and combined reconstruction.MethodsElectronic databases, including Medline/PubMed, Embase and the Cochrane Library, were systematically searched to identify targeted studies. A meta-analysis were performed to pool the outcome estimates of interest, such as the Lysholm, International Knee Documentation Committee (IKDC) and Tegner scores and the results from the KT-1000/2000 arthrometer test, the Lachman test and the pivot shift test.ResultsTwelve studies involving 1146 knees were identified. Compared with single ACL reconstruction, combined reconstruction had better results for a pivot shift of grade 1 (relative ratio [RR] = 0.88, 95% CI: 0.83-0.94) and grade 2 (RR = 0.95, 95% CI: 0.91-0.99) rather than grade 3 (RR = 0.98, 95% CI: 0.90-1.06) and no statistically significant difference for both Lachman grade 1 (RR = 0.96, 95% CI: 0.89-1.05) and grade 2 (RR = 0.96, 95% CI: 0.90-1.03). Combined reconstruction resulted in significant improvements on the instrumented joint laxity test when considering a failure standard of more than 5 mm (a side-to-side arthrometric difference) (RR = 0.94, 95% CI: 0.89-0.98) rather than 3 mm (RR = 0.94, 95% CI: 0.86-1.03). Moreover, combined reconstruction increased the IKDC score at the 12-month (weighted mean difference [WMD] = - 6.38, 95% CI: - 9.66 to - 3.10), 24-month (WMD = - 5.60, 95% CI: - 8.54 to - 2.66) and 36-month follow-ups (WMD = - 4.71, 95% CI: - 7.59 to - 1.83) and the Tegner score at the 36-month follow-up (WMD = - 0.53, 95% CI: - 0.97 to - 0.09), but it did not increase the Lysholm score at the 36-month follow-up (WMD = - 0.84, 95% CI: - 2.02 to 0.34).ConclusionWith the advances in reconstruction techniques, combined reconstructions were found to be effective in improving rotational stability and to lead to good functional scores. However, obviously, the combined reconstruction technique is more time-consuming and requires an additional incision, which is not suitable for all ACL-deficient patients. Therefore, programs should be personalized and customized for the specific situation of each patient.

Dataset Information

The Stability study: a protocol for a multicenter randomized clinical trial comparing anterior cruciate ligament reconstruction with and without Lateral Extra-articular Tenodesis in individuals who are at high risk of graft failure.

Publications

The Stability study: a protocol for a multicenter randomized clinical trial comparing anterior cruciate ligament reconstruction with and without Lateral Extra-articular Tenodesis in individuals who are at high risk of graft failure.

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