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动态关节内稳定与急性前交叉韧带撕裂的初次重建修复:一项前瞻性随机研究的 2 年结果。

Repair With Dynamic Intraligamentary Stabilization Versus Primary Reconstruction of Acute Anterior Cruciate Ligament Tears: 2-Year Results From a Prospective Randomized Study.

机构信息

Department of Trauma, Hand and Reconstructive Surgery, University Hospital Münster, Münster, Germany.

出版信息

Am J Sports Med. 2020 Apr;48(5):1108-1116. doi: 10.1177/0363546520905863. Epub 2020 Mar 3.

Abstract

BACKGROUND

Anterior cruciate ligament (ACL) repair has once again become a focus of research because of the development of new techniques.

PURPOSE/HYPOTHESIS: The purpose was to compare the functional results and recurrent instability rates in patients undergoing ACL repair with dynamic intraligamentary stabilization (DIS) versus primary ACL reconstruction (ACLR) for acute isolated ACL tears. The hypothesis was that functional results and knee joint stability after ACL repair with DIS would be comparable with that after ACLR.

STUDY DESIGN

Randomized clinical trial; Level of evidence, 1.

METHODS

A total of 85 patients with acute ACL tears were randomized to undergo either ACL repair with DIS or primary ACLR. The preinjury activity level and function were recorded. Follow-up examinations were performed at 6 weeks and 6, 12, and 24 months postoperatively. Anterior tibial translation (ATT) was evaluated using Rolimeter testing. The Tegner activity scale, International Knee Documentation Committee (IKDC) subjective form, and Lysholm knee scoring scale scores were obtained. Clinical failure was defined as ΔATT >3 mm in combination with subjective instability. Recurrent instability and other complications were recorded.

RESULTS

There were 83 patients (97.6%) who were successfully followed until 2 years. ATT was significantly increased in the DIS group compared with the ACLR group (ΔATT, 1.9 vs 0.9 mm, respectively; = .0086). A total of 7 patients (16.3%) in the DIS group had clinical failure and underwent single-stage revision. In the ACLR group, 5 patients (12.5%) had failure of the reconstruction procedure; 4 of these patients required 2-stage revision. The difference in the failure rate was not significant ( = .432). There were 4 patients (3 in the DIS group and 1 in the ACLR group) who showed increased laxity (ΔATT >3 mm) without subjective instability and did not require revision. Recurrent instability was associated with young age (<25 years) and high Tegner scores (>6) in both groups. No significant differences between ACL repair with DIS and ACLR were found for the Tegner, IKDC, and Lysholm scores at any time.

CONCLUSION

Whereas ATT measured by Rolimeter testing was significantly increased after ACL repair with DIS, clinical failure was similar to that after ACLR. In addition, functional results after ACL repair with DIS for acute tears were comparable with those after ACLR. The current study supports the use of ACL repair with DIS as an option to treat acute ACL tears.

REGISTRATION

DRKS00015466 (German Clinical Trials Register).

摘要

背景

随着新技术的发展,前交叉韧带(ACL)修复再次成为研究焦点。

目的/假设:本研究旨在比较急性单纯 ACL 撕裂患者接受动态关节内稳定术(DIS)与 ACL 重建术(ACLR)后 ACL 修复的功能结果和复发性不稳定率。假设是,DIS 后 ACL 修复的功能结果和膝关节稳定性与 ACLR 后相似。

研究设计

随机临床试验;证据水平,1 级。

方法

85 例急性 ACL 撕裂患者随机分为 DIS 组和 ACLR 组。记录术前活动水平和功能。术后 6 周和 6、12、24 个月进行随访检查。使用 Rolimeter 测试评估胫骨前移(ATT)。获得 Tegner 活动量表、国际膝关节文献委员会(IKDC)主观评分和 Lysholm 膝关节评分。临床失败定义为 Rolimeter 测试 ΔATT>3mm 合并主观不稳定。记录复发性不稳定和其他并发症。

结果

83 例患者(97.6%)成功随访至 2 年。DIS 组 ATT 明显高于 ACLR 组(ΔATT 分别为 1.9mm 和 0.9mm;P=.0086)。DIS 组有 7 例(16.3%)患者发生临床失败并接受单阶段翻修。ACLR 组 5 例(12.5%)患者重建失败,其中 4 例需要 2 阶段翻修。失败率无显著差异(P=.432)。DIS 组和 ACLR 组各有 4 例(3 例和 1 例)患者出现 Rolimeter 测试 ΔATT>3mm 但无主观不稳定,无需翻修。两组中 Rolimeter 测试 ΔATT>3mm 但无主观不稳定的复发性不稳定与年龄较小(<25 岁)和 Tegner 评分较高(>6)有关。在任何时间点,DIS 后 ACL 修复与 ACLR 相比,Tegner、IKDC 和 Lysholm 评分均无显著差异。

结论

虽然 Rolimeter 测试测量的 DIS 后 ACL 修复 ATT 明显增加,但临床失败与 ACLR 相似。此外,急性 ACL 撕裂 DIS 后 ACL 修复的功能结果与 ACLR 相似。本研究支持将 DIS 后 ACL 修复作为治疗急性 ACL 撕裂的一种选择。

登记号

DRKS00015466(德国临床试验注册)。

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