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Bridge-Enhanced ACL Repair: Two Year Results of the First In Human Study

机译:桥梁增强的ACL维修:首次人类研究的两年结果

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Objectives: The Bridge-Enhanced ACL Repair (BEAR) procedure is an alternate form of anterior cruciate ligament (ACL) surgery that involves suture repair of the ligament combined with a scaffold to bridge the gap between the torn ligament ends. In this paper, we report outcomes of this procedure and a non-randomized concurrent control group receiving ACL reconstruction with quadrupled hamstring tendon autograft. We hypothesized that patients treated with Bridge-Enhanced ACL Repair would have physical exam findings, patient reported outcomes and adverse events at one and two years that were similar to patients treated with ACL reconstruction. Methods: This was an observational cohort study. Twenty patients were enrolled. Ten patients received a Bridge-Enhanced ACL Repair (BEAR ~(?)) and 10 received a hamstring autograft ACL reconstruction. Outcomes were assessed at time points up to 2 years post-operatively, including the International Knee Documentation Committee (IKDC) Subjective Score, the IKDC Objective score, KT-1000 testing for AP laxity and functional testing. Results: There were no graft or repair failures in the first two years after surgery. The IKDC Subjective Scores in both groups improved significantly from baseline (p& 0.0001) but were similar in BEAR and ACL reconstruction groups at 12 and 24 months. An IKDC Objective score of A (normal) was found in 44% of the patients in the BEAR group and 29% of the patients in the ACL reconstruction group at two years; no patients in either group had a grade of C (abnormal) or D (severely abnormal). KT-1000 testing demonstrated a side to side difference that was similar in the two groups at 2 years (mean(±SD) 1.9(± 2.1) mm in the BEAR group, 3.1(± 2.7) mm in the ACLR group). Functional hop testing results were similar in the two groups at 1 and 2 years after surgery. Hamstring strength indices measured by dynamometer were significantly higher at all time points in the BEAR group than in the hamstring autograft group (mean percentages relative to contralateral side at two years, 98.6%(±10.5%) vs 56.3%(±19.0%), p=0.0001). Conclusion: In a small first-in-human study, Bridge-Enhanced ACL Repair produced similar outcomes to ACL reconstruction with autograft quadruple bundle hamstring tendon.
机译:目标:桥增强ACL修复(BEAR)手术是前交叉韧带(ACL)手术的另一种形式,涉及韧带的缝合修复和支架,以桥接韧带两端之间的间隙。在本文中,我们报告了该程序的结果以及接受四叉CL绳肌腱自体移植重建ACL的非随机并发对照组。我们假设接受桥强化ACL修复治疗的患者将进行体格检查,发现患者在一年和两年内报告的结局和不良事件与接受ACL重建的患者相似。方法:这是一项观察性队列研究。招募了20名患者。 10例患者接受了桥增强ACL修复(BEAR〜(?)),其中10例接受了绳肌自体移植ACL重建术。在术后2年的时间点评估结局,包括国际膝关节文献委员会(IKDC)主观评分,IKDC客观评分,AP松弛度的KT-1000测试和功能测试。结果:术后头两年没有发生移植或修复失败。两组的IKDC主观评分均较基线有显着改善(p <0.0001),但BEAR和ACL重建组在12和24个月时相似。两年后,在BEAR组的44%的患者和ACL重建组的29%的患者中,IKDC客观得分为A(正常)。两组中均无C级(异常)或D级(严重异常)的患者。 KT-1000测试显示两组在2年时的左右差异相似(BEAR组平均(±SD)1.9(±2.1)mm,ACLR组平均3.1(±2.7)mm)。两组在术后1年和2年的功能性跳频测试结果相似。 BEAR组在所有时间点通过测力计测得的绳肌力量指数均显着高于the绳肌自体移植组(两年中相对于对侧的平均百分比,分别为98.6%(±10.5%)和56.3%(±19.0%), p = 0.0001)。结论:在一项小型的首次人类研究中,Bridge-Enhanced ACL Repair的效果与自体四联bundle绳肌腱重建ACL相似。

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