Department of Orthopaedic Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Department of Orthopaedic Surgery, Spaarne Gasthuis, Hoofddorp, The Netherlands.
BMC Musculoskelet Disord. 2021 Apr 30;22(1):399. doi: 10.1186/s12891-021-04280-y.
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.
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.
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.
Registered at Netherlands Trial Register ( NL9072 ) on 25th of November 2020.
对于想要恢复活跃运动水平的前交叉韧带（ACL）撕裂的活跃患者，目前的手术金标准是 ACL 重建。最近，在选择的近端撕裂韧带患者中，修复 ACL 再次引起了人们的兴趣。与重建韧带相比，修复韧带具有（潜在）优势，如手术发病率降低、运动范围更快恢复，并且可能降低对膝关节的认识。目前缺乏比较两种治疗方法的前瞻性随机方法的研究。
这项研究是一项多中心前瞻性分组随机对照试验。共有 74 名急性近端孤立性 ACL 撕裂患者将以 1:1 的分配比例随机分配至（I）使用皮质纽扣固定和额外缝线增强的 ACL 修复或（II）使用全内自体腘绳肌腱移植物技术的 ACL 重建。主要目的是评估 ACL 修复在术后两年时的主观国际膝关节文献委员会（IKDC）评分方面是否不劣于 ACL 重建。次要目标是评估 ACL 修复在以下方面是否不劣于 ACL 重建：（I）其他患者报告的结果测量（即膝关节损伤和骨关节炎结果评分、Lysholm 评分、遗忘关节评分、患者满意度和疼痛），（II）客观结果测量（即修复或移植物失败定义为再撕裂或症状性不稳定、再次手术、对侧损伤以及使用客观 IKDC 评分和 Rollimeter/KT-2000 评估的稳定性），（III）通过 Tegner 活动评分和 ACL 重返运动指数在两年随访时评估重返运动情况，以及（IV）在 10 年随访时评估长期骨关节炎。
在过去十年中，修复近端撕裂的 ACL 再次引起了人们的兴趣。几项队列研究使用这些技术显示出令人鼓舞的短期和中期结果，但缺乏前瞻性随机研究。因此，这项随机对照试验旨在评估 ACL 修复在主观和客观结果评分方面是否至少与 ACL 重建的当前金标准相当。
于 2020 年 11 月 25 日在荷兰临床试验注册中心（NL9072）注册。
