Department of Trauma, Hand and Reconstructive Surgery, University Hospital Münster, Münster, Germany.
OCM Munich, Munich, Germany.
Am J Sports Med. 2022 Oct;50(12):3256-3264. doi: 10.1177/03635465221117777. Epub 2022 Aug 25.
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.
Randomized controlled trial; Level of evidence, 1.
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 test, and Bonferroni correction were applied for statistical comparisons with significance set at < .05.
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 ( = .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 ( = .322), respectively, and the mean IKDC subjective score was 94.1 ± 9.9 versus 89.9 ± 7.8 ( = .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 ( = .09) or ACL revision surgery ( = .118) were not statistically significant. Recurrent instability was associated with age <25 years and Tegner score >7 in both groups.
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).
DRKS00015466 (German Clinical Trials Register).
技术创新使得前交叉韧带(ACL)修复在过去十年中复兴。
目的/假设:本研究旨在比较急性孤立 ACL 撕裂后 ACL 修复与初次 ACL 重建后关节内松弛度和患者报告的结果(PROs)。假设 ACL 修复后 5 年的膝关节稳定性和 PROs 与 ACL 重建相当。
随机对照试验;证据水平,1 级。
85 例急性 ACL 撕裂患者随机分为采用动态内韧带稳定化(DIS)的 ACL 修复或半腱肌腱自体移植物的初次 ACL 重建。主要结局是 Rolimeter 测试在术后 5 年时的前胫骨平移(ΔATT)的侧间差异。随访检查在 1、2 和 5 年进行。PROs 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。进行了事先的功效分析,应用 Friedman 检验、Mann-Whitney U 检验和 Bonferroni 校正进行统计比较,显著性水平设为<.05。
ACL 修复组的平均年龄为 28.3±11.5 岁,ACL 重建组为 27.1±11.5 岁。术后 5 年时,共有 64 例患者(ACL 修复组:n=43 例中的 34 例[79%];ACL 重建组:n=42 例中的 30 例[71%])可进行随访。术后 5 年时,ACL 修复组的 ΔATT 为 1.7±1.6mm,ACL 重建组为 1.4±1.3mm( =.334)。两组患者的术前 PROs 在术后 1 年即可恢复,直至术后 2 年和 5 年达到平台期。在 5 年随访时,ACL 修复组的平均 Lysholm 评分为 97.0±5.4,ACL 重建组为 94.5±5.5( =.322),分别为,而 IKDC 主观评分分别为 94.1±9.9 和 89.9±7.8( =.047)。在术后 5 年时,ACL 修复组有 12 例患者(35%;年龄<25 岁:n=10/12;Tegner 评分≥7:n=10/12)出现复发性不稳定,其中 10 例患者行单阶段翻修 ACL 重建。在 ACL 重建组中,有 6 例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,在 5 例患者中,需要分期翻修。两组之间复发性不稳定( =.09)或 ACL 翻修手术( =.118)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。
在 ACL 修复后 5 年时,用 DIS 进行的关节内松弛度和 PROs 与 ACL 重建相当。尽管修复与重建之间没有发现显著差异,但需要对复发性不稳定(分别为 35%和 20%)和翻修手术(分别为 38%和 27%)的发生率进行批判性评估。两组中年轻年龄和较高的术前活动水平是复发性不稳定的主要危险因素。然而,在 ACL 修复组中,每个病例都可以进行单阶段翻修 ACL 重建。尽管 ACL 重建仍然是 ACL 撕裂治疗的金标准,但本研究支持使用 DIS 进行 ACL 修复作为治疗年龄≥25 岁、活动水平低至中度(Tegner 评分<7)的急性 ACL 撕裂的可行选择。
DRKS00015466(德国临床试验注册)。