小柯机器人

荷兰伊拉斯谟大学医学中心Max Reijman团队比较了早期手术重建与选择性延迟重建治疗前交叉韧带断裂患者的疗效。2021年3月9日，该研究发表在《英国医学杂志》上。

为了探讨两种常用治疗方案在前交叉韧带断裂（ACL）破裂后两年内，患者对症状、膝功能和参与运动能力的认知是否存在临床相关差异，2011年5月至2016年4月，研究组在荷兰的6家医院进行了一项开放标签、多中心、平行、随机对照试验，招募年龄在18-65岁的急性前交叉韧带断裂患者，分别在3个月、6个月、9个月、12个月和24个月时对患者进行评估。

将患者随机分组，其中85例接受早期ACL重建；82例先接受康复治疗，之后选择性延迟ACL重建，为期三个月（原发性非手术治疗）。主要结局为在24个月的每个时间点，采用国际膝关节文献委员会评分（最佳评分100分）来评估患者对症状、膝关节功能和参与运动能力的认知。

2011年5月至2016年4月，共有167名患者被纳入研究，平均年龄为31.3岁，67名（40%）为女性，共有163名（98%）患者完成了试验。在康复和选择性延迟ACL重建组中，41例（50%）患者在随访中接受重建。24个月后，早期ACL重建组的国际膝关节文献委员会评分显著优于康复和选择性延迟ACL重建组，但与临床无关。

随访3个月后，康复和选择性延迟ACL重建组的国际膝关节文献委员会评分显著更优。随访9个月后，早期ACL重建组的国际膝关节文献委员会评分更优。12个月后，两组之间的差异较小。早期ACL重建组随访时发生4例ACL再断裂和3例对侧ACL断裂，而康复和选择性延迟ACL重建组则分别发生2例和1例。

研究结果表明，急性前交叉韧带断裂患者接受早期手术重建，在2年的随访中，对症状、膝关节功能和运动能力的认知都有所改善。这一发现意义重大，但临床重要性尚不清楚。

附：英文原文

Title: Early surgical reconstruction versus rehabilitation with elective delayed reconstruction for patients with anterior cruciate ligament rupture: COMPARE randomised controlled trial

Author: Max Reijman, Vincent Eggerding, Eline van Es, Ewoud van Arkel, Igor van den Brand, Joost van Linge, Jacco Zijl, Erwin Waarsing, Sita Bierma-Zeinstra, Duncan Meuffels

Issue&Volume: 2021/03/09

Abstract:

Objective To assess whether a clinically relevant difference exists in patients’ perceptions of symptoms, knee function, and ability to participate in sports over a period of two years after rupture of the anterior cruciate ligament (ACL) between two commonly used treatment regimens.

Design Open labelled, multicentre, parallel randomised controlled trial (COMPARE).

Setting Six hospitals in the Netherlands, between May 2011 and April 2016.

Participants Patients aged 18 to 65 with an acute rupture of the ACL, recruited from six hospitals. Patients were evaluated at three, six, nine, 12, and 24 months.

Interventions 85 patients were randomised to early ACL reconstruction and 82 to rehabilitation followed by optional delayed ACL reconstruction after a three month period (primary non-operative treatment).

Main outcomes Patients’ perceptions of symptoms, knee function, and ability to participate in sporting activities were assessed with the International Knee Documentation Committee score (optimum score 100) at each time point over 24 months.

Results Between May 2011 and April 2016, 167 patients were enrolled in the study and randomised to one of two treatments (mean age 31.3; 67 (40.%) women), and 163 (98%) completed the trial. In the rehabilitation and optional delayed ACL reconstruction group, 41 (50%) patients underwent reconstruction during follow-up. After 24 months, the early ACL reconstruction group had a significantly better (P=0.026) but not clinically relevant International Knee Documentation Committee score (84.7 v 79.4 (difference between groups 5.3, 95% confidence interval 0.6 to 9.9). After three months of follow-up, the International Knee Documentation Committee score was significantly better (P=0.002) for the rehabilitation and optional delayed ACL reconstruction group (difference between groups 9.3, 14.6 to 4.0). After nine months of follow-up, the difference in the International Knee Documentation Committee score changed in favour of the early ACL reconstruction group. After 12 months, differences between the groups were smaller. In the early ACL reconstruction group, four re-ruptures and three ruptures of the contralateral ACL occurred during follow-up versus two re-ruptures and one rupture of the contralateral ACL in the rehabilitation and optional delayed ACL reconstruction group.

Conclusions In patients with acute rupture of the ACL, those who underwent early surgical reconstruction, compared with rehabilitation followed by elective surgical reconstruction, had improved perceptions of symptoms, knee function, and ability to participate in sports at the two year follow-up. This finding was significant (P=0.026) but the clinical importance is unclear. Interpretation of the results of the study should consider that 50% of the patients randomised to the rehabilitation group did not need surgical reconstruction.

DOI: 10.1136/bmj.n375

Source: https://www.bmj.com/content/372/bmj.n375

BMJ-British Medical Journal:《英国医学杂志》，创刊于1840年。隶属于BMJ出版集团，最新IF：93.333
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