Repair versus reconstruction for proximal anterior cruciate ligament tears: a study protocol for a prospective multicenter randomized controlled trial

Abstract

Background 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. 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. Methods This 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. Discussion Over 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 registration Registered at Netherlands Trial Register (NL9072) on 25th of November 2020.

Prospective Comparison of Postoperative Pain and Opioid Consumption Between Primary Repair and Reconstruction of the Anterior Cruciate Ligament

“…The less invasive nature of ACL repair surgery likely plays an important role in these differences. With ACL repair, the native tissues of the ligament are preserved, only small tunnels are drilled (3.5 vs 7-11 mm), 28 and there is no need for graft harvesting, thus eliminating graft site morbidity. 9,31 When reviewing the literature, only 2 studies have assessed pain and postoperative opioid use after primary ACL repair.…”

Arthroscopic primary repair of the anterior cruciate ligament: rationale, patient selection and early outcomes (PhD Academy Award)

“…Next, we assessed the outcomes of arthroscopic ACL repair in our first cohort of 56 patients (with 100% follow-up)6 and assessed the outcomes that have been reported in the literature 7. Finally, we presented a design for an RCT in which we will compare primary repair with reconstruction in patients with proximal ACL tears 8…”

Do the Differences in the Epiligament of the Proximal and Distal Parts of the Anterior Cruciate Ligament Explain Their Different Healing Capacities? Quantitative and Immunohistochemical Analysis of CD34 and α-SMA Expression in Relation to the Epiligament Theory

“…Formerly, primary repair of the ACL injury was performed, but no healing was established in more than 90% of cases [2,3]. Subsequently, ACL reconstruction with a tendon graft was accepted as the gold standard of treatment, especially for active patients who wanted to return to sports [3,4]. Nevertheless, progressive articular cartilage degeneration was established [3,5].…”