Background:

Technical innovation has led to the renaissance of anterior cruciate ligament (ACL) repair in the past decade.

Purpose/Hypothesis:

The present study aimed to compare instrumented knee joint laxity and patient-reported outcomes (PROs) after ACL repair with those after primary ACL reconstruction for acute isolated ACL tears. It was hypothesized that ACL repair would lead to comparable knee joint stability and PROs at 5 years postoperatively in comparison with ACL reconstruction.

Study Design:

Randomized controlled trial; Level of evidence, 1.

Methods:

A total of 85 patients with acute ACL tears were randomized to undergo either ACL repair using dynamic intraligamentary stabilization (DIS) or primary ACL reconstruction with a semitendinosus tendon autograft. The primary outcome was the side-to-side difference in anterior tibial translation (ΔATT) assessed by Rolimeter testing at 5 years postoperatively. Follow-up examinations were performed at 1, 2, and 5 years. PROs were assessed using the Tegner activity scale, the International Knee Documentation Committee (IKDC) subjective score, and the Lysholm score. Furthermore, the rates of recurrent instability, other complications, and revision surgery were recorded. A power analysis was performed a priori, and the Friedman test, Mann-Whitney U test, and Bonferroni correction were applied for statistical comparisons with significance set at P < .05.

Results:

The mean age at inclusion was 28.3 ± 11.5 years in the ACL repair group and 27.1 ± 11.5 years in the ACL reconstruction group. At 5 years postoperatively, a total of 64 patients (ACL repair: n = 34 of 43 [79%]; ACL reconstruction: n = 30 of 42 [71%]) were available for follow-up. At 5 years, ΔATT was 1.7 ± 1.6 mm in the ACL repair group and 1.4 ± 1.3 mm in the ACL reconstruction group (P = .334). Preinjury PROs were restored as soon as 1 year after surgery and plateaued until 2 and 5 years postoperatively in both groups. At the 5-year follow-up, the mean Lysholm score was 97.0 ± 5.4 versus 94.5 ± 5.5 (P = .322), respectively, and the mean IKDC subjective score was 94.1 ± 9.9 versus 89.9 ± 7.8 (P = .047), respectively, in the ACL repair group versus ACL reconstruction group. At 5 years postoperatively, 12 patients in the ACL repair group (35%; age <25 years: n = 10/12; Tegner score ≥7: n = 10/12) had recurrent instability, of whom 10 underwent single-stage revision ACL reconstruction. In the ACL reconstruction group, there were 6 patients with recurrent instability (20%; age <25 years: n = 6/6; Tegner score ≥7: n = 5/6); however, in 5 patients, staged revision was required. Differences between both groups regarding recurrent instability (P = .09) or ACL revision surgery (P = .118) were not statistically significant. Recurrent instability was associated with age <25 years and Tegner score >7 in both groups.

Conclusion:

At 5 years after ACL repair with DIS, instrumented knee joint laxity and PROs were comparable with those after ACL reconstruction. Although no significant difference was found between repair and reconstruction, a critical appraisal of the rates of recurrent instability (35% vs 20%, respectively) and revision surgery (38% vs 27%, respectively) is needed. Young age and a high preinjury activity level were the main risk factors for recurrent instability in both groups. However, single-stage revision ACL reconstruction was possible in each case in the ACL repair group. Although ACL reconstruction remains the gold standard in the treatment of ACL tears, the present study supports the use of ACL repair with DIS as a feasible option to treat acute ACL tears in patients aged ≥25 years with low to moderate activity levels (Tegner score <7).

Registration:

DRKS00015466 (German Clinical Trials Register).

中文翻译：

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通过动态韧带内稳定或 ACL 重建修复 ACL 后可比较的器械膝关节松弛度和患者报告的结果：随机对照试验的 5 年结果

背景：

在过去十年中，技术创新导致了前交叉韧带 (ACL) 修复的复兴。

目的/假设：

本研究旨在比较 ACL 修复后与初次 ACL 重建急性孤立性 ACL 撕裂后的膝关节松弛度和患者报告结果 (PRO)。据推测，与 ACL 重建相比，ACL 修复术后 5 年的膝关节稳定性和 PROs 相当。

学习规划：

随机对照试验; 证据等级，1。

方法：

共有 85 名急性 ACL 撕裂患者被随机分配接受使用动态韧带内稳定 (DIS) 进行的 ACL 修复或使用半腱肌腱自体移植进行原发性 ACL 重建。主要结果是术后 5 年通过 Rolimeter 测试评估的胫骨前移 (ΔATT) 的左右差异。在第 1、2 和 5 年进行随访检查。PRO 使用 Tegner 活动量表、国际膝关节文献委员会 (IKDC) 主观评分和 Lysholm 评分进行评估。此外，还记录了复发性不稳定、其他并发症和翻修手术的发生率。先验地进行功效分析，弗里德曼检验，Mann-Whitney U检验和 Bonferroni 校正用于统计比较，显着性设置为P < .05。

结果：

ACL 修复组纳入时的平均年龄为 28.3 ± 11.5 岁，ACL 重建组为 27.1 ± 11.5 岁。术后 5 年，共有 64 名患者（ACL 修复：43 人中的 n = 34 [79%]；ACL 重建：42 人中的 n = 30 [71%]）可用于随访。5 年时，ACL 修复组的 ΔATT 为 1.7 ± 1.6 mm，ACL 重建组为 1.4 ± 1.3 mm ( P = .334)。两组的伤前 PROs 在术后 1 年恢复，并在术后 2 年和 5 年达到稳定水平。在 5 年随访时，平均 Lysholm 评分分别为 97.0 ± 5.4 和 94.5 ± 5.5 ( P = .322)，平均 IKDC 主观评分分别为 94.1 ± 9.9 和 89.9 ± 7.8 ( P= .047)，分别在 ACL 修复组和 ACL 重建组中。术后 5 年，ACL 修复组中有 12 名患者（35%；年龄 <25 岁：n = 10/12；Tegner 评分≥7：n = 10/12）出现反复不稳定，其中 10 名接受了单期翻修ACL重建。在 ACL 重建组中，有 6 名患者出现复发性不稳定（20%；年龄 <25 岁：n = 6/6；Tegner 评分≥7：n = 5/6）；然而，有 5 名患者需要分期翻修。两组在复发性不稳定 ( P = .09) 或 ACL 翻修手术 ( P = .118) 方面的差异无统计学意义。复发性不稳定与两组的年龄 <25 岁和 Tegner 评分 >7 相关。

结论：

在用 DIS 修复 ACL 后 5 年，仪器化的膝关节松弛度和 PROs 与 ACL 重建后的相当。虽然修复和重建之间没有发现显着差异，但需要对复发性不稳定性（分别为 35% 和 20%）和修复手术（分别为 38% 和 27%）的发生率进行严格评估。年轻和受伤前的高活动水平是两组反复出现不稳定的主要危险因素。然而，在 ACL 修复组的每个病例中，单阶段翻修 ACL 重建都是可能的。尽管 ACL 重建仍然是治疗 ACL 撕裂的金标准，但本研究支持将 ACL 修复与 DIS 作为治疗年龄≥25 岁且低至中度活动水平（Tegner 评分 < 7).

登记：

DRKS00015466（德国临床试验注册）。