Abstract
BackgroundFor active patients with a tear of the anterior cruciate ligament (ACL) who would like to return to active level of sports, the current surgical gold standard is reconstruction of the ACL. Recently, there has been renewed interest in repairing the ACL in selected patients with a proximally torn ligament. Repair of the ligament has (potential) advantages over reconstruction of the ligament such as decreased surgical morbidity, faster return of range of motion, and potentially decreased awareness of the knee. Studies comparing both treatments in a prospective randomized method are currently lacking.MethodsThis study is a multicenter prospective block randomized controlled trial. A total of 74 patients with acute proximal isolated ACL tears will be assigned in a 1:1 allocation ratio to either (I) ACL repair using cortical button fixation and additional suture augmentation or (II) ACL reconstruction using an all-inside autologous hamstring graft technique. The primary objective is to assess if ACL repair is non-inferior to ACL reconstruction regarding the subjective International Knee Documentation Committee (IKDC) score at two-years postoperatively. The secondary objectives are to assess if ACL repair is non-inferior with regards to (I) other patient-reported outcomes measures (i.e. Knee Injury and Osteoarthritis Outcome Score, Lysholm score, Forgotten Joint Score, patient satisfaction and pain), (II) objective outcome measures (i.e. failure of repair or graft defined as rerupture or symptomatic instability, reoperation, contralateral injury, and stability using the objective IKDC score and Rollimeter/KT-2000), (III) return to sports assessed by Tegner activity score and the ACL-Return to Sports Index at two-year follow-up, and (IV) long-term osteoarthritis at 10-year follow-up.DiscussionOver the last decade there has been a resurgence of interest in repair of proximally torn ACLs. Several cohort studies have shown encouraging short-term and mid-term results using these techniques, but prospective randomized studies are lacking. Therefore, this randomized controlled trial has been designed to assess whether ACL repair is at least equivalent to the current gold standard of ACL reconstruction in both subjective and objective outcome scores.Trial registrationRegistered at Netherlands Trial Register (NL9072) on 25th of November 2020.
Highlights
For active patients with a tear of the anterior cruciate ligament (ACL) who would like to return to active level of sports, the current surgical gold standard is reconstruction of the ACL
Several cohort studies have shown encouraging short-term and mid-term results using these techniques, but prospective randomized studies are lacking. This randomized controlled trial has been designed to assess whether ACL repair is at least equivalent to the current gold standard of ACL reconstruction in both subjective and objective outcome scores
This study reports on the study design of the REPAIRtrial (Repair versus rEconstruction for Proximal Anterior cruciate lIgament teaRs)
Summary
This study and manuscript have been designed in accordance to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. IKDC indicates International Knee Documentation Committee, KOOS Knee Injury and Osteoarthritis Outcome Score, AE adverse events, SAE serious adverse event, SUSAR Suspected Unexpected Serious Adverse Reaction, Pre preoperatively, mns months, yr(s) year(s) shown that a difference of 8.8 points in the subjective IKDC score is the minimal clinically important difference (MCID) [76] Using this non-inferiority limit of 8.8 points, and a standard deviation of 11 points [42, 65, 77] along with a two-sided alpha of 0.05, a power of 90%, and a lost-to-follow-up rate of 10%, a total of 37 patients in each group (74 patients in total) are needed to assess the primary outcome of this non-inferiority RCT. All tests are two-sided and a p-value of < 0.05 is considered statistically significant
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