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急性前交叉韧带撕裂:修复还是重建?一项随机对照临床试验的两年结果。

Acute Anterior Cruciate Ligament Rupture: Repair or Reconstruction? Two-Year Results of a Randomized Controlled Clinical Trial.

机构信息

Centre for Orthopaedic Surgery OCON, Hengelo, the Netherlands.

Department of Orthopaedic Surgery, Martini Hospital, Groningen, the Netherlands.

出版信息

Am J Sports Med. 2019 Mar;47(3):567-577. doi: 10.1177/0363546519825878.

Abstract

BACKGROUND

Contemporary anterior cruciate ligament (ACL) suture repair techniques have been subject to renewed interest in recent years. Although several clinical studies have yielded good short-term results, high-quality evidence is lacking in regard to the effectiveness of this treatment compared with ACL reconstruction.

HYPOTHESIS

Dynamic augmented ACL suture repair is at least as effective as anatomic single-bundle ACL reconstruction for the treatment of acute ACL rupture in terms of patient self-reported outcomes at 2 years postoperatively.

STUDY DESIGN

Randomized controlled trial; Level of evidence, 1.

METHODS

After stratification and randomization, 48 patients underwent either dynamic augmented ACL suture repair or ACL reconstruction with a single-bundle, all-inside, semitendinosus technique. The International Knee Documentation Committee (IKDC) subjective score at 2 years postoperatively was the primary outcome measure. Patient-reported outcomes (IKDC subjective score, Knee injury and Osteoarthritis Outcome Score, Tegner score, visual analog scale for satisfaction), clinical outcomes (IKDC physical examination score, leg symmetry index for the quadriceps, hamstrings strength, and jump test battery), and radiological outcomes as well as adverse events including reruptures were recorded. Analyses were based on an intention-to-treat principle.

RESULTS

The lower limit for the median IKDC subjective score of the repair group (86.2) fell within the prespecified noninferiority margin, confirming noninferiority of dynamic augmented ACL suture repair compared with ACL reconstruction. No statistical difference was found between groups for median IKDC subjective score (repair, 95.4; reconstruction, 94.3). Overall, 2 reruptures (8.7%) occurred in the dynamic ACL suture repair group and 4 reruptures (19.0%) in the ACL reconstruction group; further, 5 repeat surgeries-other than for revision ACL surgery-took place in 4 patients from the dynamic ACL suture repair group (20.8%) and in 3 patients from the ACL reconstruction group (14.3%).

CONCLUSION

Dynamic augmented ACL suture repair is not inferior to ACL reconstruction in terms of subjective patient-reported outcomes as measured with the IKDC subjective score 2 years postoperatively. However, for reasons other than revision ACL surgery due to rerupture, a higher number of related adverse events leading to repeat surgery were seen in the dynamic augmented ACL suture repair group within 2 years postoperatively.

CLINICAL RELEVANCE

Dynamic augmented ACL suture repair might be a viable treatment option for patients with an acute ACL rupture.

REGISTRATION

NCT02310854 ( ClinicalTrials.gov identifier).

摘要

背景

近年来,对当代前交叉韧带(ACL)缝合修复技术的兴趣重新燃起。尽管多项临床研究取得了良好的短期结果,但与 ACL 重建相比,这种治疗方法的有效性仍缺乏高质量的证据。

假设

在术后 2 年时,与 ACL 重建相比,动态增强 ACL 缝合修复在治疗急性 ACL 撕裂方面,在患者自我报告的结果方面,至少与解剖学单束 ACL 重建同样有效。

研究设计

随机对照试验;证据水平,1 级。

方法

在分层和随机化后,48 例患者接受了动态增强 ACL 缝合修复或单束、全内、半腱肌技术的 ACL 重建。术后 2 年时的国际膝关节文献委员会(IKDC)主观评分是主要的观察指标。记录患者报告的结果(IKDC 主观评分、膝关节损伤和骨关节炎结果评分、Tegner 评分、满意度视觉模拟评分)、临床结果(IKDC 体格检查评分、股四头肌和腘绳肌的腿对称指数、肌力、跳跃测试)、影像学结果以及包括再断裂在内的不良事件。分析基于意向治疗原则。

结果

修复组的 IKDC 主观评分中位数下限落在预设的非劣效性边界内,证实了与 ACL 重建相比,动态增强 ACL 缝合修复的非劣效性。修复组和重建组之间的 IKDC 主观评分中位数无统计学差异(修复组 95.4,重建组 94.3)。总的来说,在动态 ACL 缝合修复组中发生了 2 例(8.7%)再断裂,在 ACL 重建组中发生了 4 例(19.0%)再断裂;此外,在动态 ACL 缝合修复组中有 4 例(20.8%)和 ACL 重建组中有 3 例(14.3%)进行了 5 次除 ACL 翻修术之外的其他重复手术。

结论

在术后 2 年时,根据 IKDC 主观评分测量,与 ACL 重建相比,动态增强 ACL 缝合修复在主观患者报告结果方面并不劣效。然而,在术后 2 年内,由于再断裂导致需要进行 ACL 翻修术以外的原因而导致的相关不良事件导致更多的重复手术,在动态增强 ACL 缝合修复组中更为常见。

临床相关性

对于急性 ACL 断裂的患者,动态增强 ACL 缝合修复可能是一种可行的治疗选择。

注册

NCT02310854(ClinicalTrials.gov 标识符)。

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