Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.
Lancet. 2022 Aug 20;400(10352):605-615. doi: 10.1016/S0140-6736(22)01424-6.
Anterior cruciate ligament (ACL) rupture is a common debilitating injury that can cause instability of the knee. We aimed to investigate the best management strategy between reconstructive surgery and non-surgical treatment for patients with a non-acute ACL injury and persistent symptoms of instability.
We did a pragmatic, multicentre, superiority, randomised controlled trial in 29 secondary care National Health Service orthopaedic units in the UK. Patients with symptomatic knee problems (instability) consistent with an ACL injury were eligible. We excluded patients with meniscal pathology with characteristics that indicate immediate surgery. Patients were randomly assigned (1:1) by computer to either surgery (reconstruction) or rehabilitation (physiotherapy but with subsequent reconstruction permitted if instability persisted after treatment), stratified by site and baseline Knee Injury and Osteoarthritis Outcome Score-4 domain version (KOOS4). This management design represented normal practice. The primary outcome was KOOS4 at 18 months after randomisation. The principal analyses were intention-to-treat based, with KOOS4 results analysed using linear regression. This trial is registered with ISRCTN, ISRCTN10110685, and ClinicalTrials.gov, NCT02980367.
Between Feb 1, 2017, and April 12, 2020, we recruited 316 patients. 156 (49%) participants were randomly assigned to the surgical reconstruction group and 160 (51%) to the rehabilitation group. Mean KOOS4 at 18 months was 73·0 (SD 18·3) in the surgical group and 64·6 (21·6) in the rehabilitation group. The adjusted mean difference was 7·9 (95% CI 2·5-13·2; p=0·0053) in favour of surgical management. 65 (41%) of 160 patients allocated to rehabilitation underwent subsequent surgery according to protocol within 18 months. 43 (28%) of 156 patients allocated to surgery did not receive their allocated treatment. We found no differences between groups in the proportion of intervention-related complications.
Surgical reconstruction as a management strategy for patients with non-acute ACL injury with persistent symptoms of instability was clinically superior and more cost-effective in comparison with rehabilitation management.
The UK National Institute for Health Research Health Technology Assessment Programme.
前交叉韧带（ACL）断裂是一种常见的使人虚弱的损伤，可导致膝关节不稳定。我们旨在研究非急性 ACL 损伤和持续不稳定症状患者的重建手术与非手术治疗之间的最佳管理策略。
我们在英国 29 家二级保健国家卫生服务骨科单位进行了一项实用、多中心、优势、随机对照试验。有症状的膝关节问题（不稳定）与 ACL 损伤一致的患者符合条件。我们排除了半月板病理有特征表明需要立即手术的患者。患者通过计算机按 1:1 随机分配到手术（重建）或康复（物理治疗，但如果治疗后仍不稳定，则允许随后进行重建）组，按部位和基线膝关节损伤和骨关节炎结果评分-4 域版本（KOOS4）分层。这种管理设计代表了常规做法。主要结局是随机分组后 18 个月的 KOOS4。主要分析是基于意向治疗的，使用线性回归分析 KOOS4 结果。该试验在 ISRCTN、ISRCTN10110685 和 ClinicalTrials.gov 上注册，NCT02980367。
2017 年 2 月 1 日至 2020 年 4 月 12 日期间，我们招募了 316 名患者。156 名（49%）参与者被随机分配到手术重建组，160 名（51%）分到康复组。手术组 18 个月时 KOOS4 的平均得分为 73.0（18.3），康复组为 64.6（21.6）。调整后的平均差值为 7.9（95%CI 2.5-13.2；p=0.0053），有利于手术治疗。根据方案，160 名被分配到康复组的患者中有 65 名（41%）在 18 个月内接受了后续手术。156 名被分配到手术组的患者中有 43 名（28%）未接受其分配的治疗。我们未发现两组间与干预相关的并发症比例存在差异。
与康复管理相比，非急性 ACL 损伤伴持续不稳定症状患者的手术重建作为一种管理策略在临床和成本效益上均具有优势。
英国国家卫生研究院健康技术评估计划。
