Background

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.

Methods

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.

Findings

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.

Interpretation

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.

Funding

The UK National Institute for Health Research Health Technology Assessment Programme.

中文翻译：

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非急性前交叉韧带损伤 (ACL SNNAP) 的康复与手术重建：一项实用的随机对照试验

背景

前十字韧带 (ACL) 断裂是一种常见的衰弱性损伤，可能导致膝关节不稳定。我们的目的是探讨对于非急性 ACL 损伤和持续不稳定症状的患者，重建手术和非手术治疗之间的最佳治疗策略。

方法

我们在英国 29 个二级保健国家卫生服务骨科单位进行了一项务实、多中心、优越性、随机对照试验。有与 ACL 损伤一致的膝关节问题（不稳定）症状的患者符合资格。我们排除了具有半月板病理学特征且需要立即手术的患者。通过计算机将患者随机分配 (1:1) 进行手术（重建）或康复治疗（物理治疗，但如果治疗后不稳定持续存在，则允许进行后续重建），按部位和基线进行分层膝关节损伤和骨关节炎结果评分 — 4 域版本 (KOOS4 ）。这种管理设计代表了正常做法。主要结局是随机分组后 18 个月时的 KOOS4。主要分析基于意向治疗，并使用线性回归分析 KOOS4 结果。该试验已在 ISRCTN（ISRCTN10110685）和 ClinicalTrials.gov（NCT02980367）注册。

发现

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%）参与者被分配到康复组。手术组 18 个月时的平均 KOOS4 为 73·0 (SD 18·3)，康复组为 64·6 (21·6)。调整后的平均差异为 7·9 (95% CI 2·5–13·2；p=0·0053)，有利于手术治疗。160 名接受康复治疗的患者中有 65 名 (41%) 在 18 个月内根据方案接受了后续手术。156 名分配手术的患者中有 43 名 (28%) 没有接受分配的治疗。我们发现干预相关并发症的比例在各组之间没有差异。

解释

与康复治疗相比，手术重建作为治疗持续不稳定症状的非急性 ACL 损伤患者的治疗策略在临床上更优越，并且更具成本效益。

资金

英国国家卫生研究院卫生技术评估计划。