Single- vs. Double-Bundle ACL Reconstruction: A Prospective Randomized Trial

描述（由申请人提供）：前交叉韧带（ACL）重建是第六大最常见的骨科手术。前交叉韧带的破坏会导致膝关节功能的改变，并显著增加骨关节炎（OA）的风险。目前重建ACL的方法通常被认为是成功的；然而，最近的几项荟萃分析表明，只有60%至70%的时间恢复了正常的膝关节结构和功能，60%至90%的患者在10至20年内有膝关节OA的影像学证据。虽然创伤后骨性关节炎的原因几乎肯定是多因素的，但导致前交叉韧带损伤和手术后骨性关节炎风险增加的一个重要因素可能是无法恢复膝关节的正常解剖和运动学。我们之前的研究表明，传统的单束（SB）前交叉韧带重建无法恢复正常的膝关节运动学，导致关节负荷模式的改变。越来越多的理论支持软骨适应其局部负载环境，异常关节负载可能在OA的发生和进展中起重要作用。在过去的几年中，我们对前交叉韧带解剖结构的理解也有所提高，揭示了当前修复前交叉韧带解剖结构的手术技术的缺点。我们已经开发了双束（DB）手术程序，以恢复正常解剖前内侧（AM）和后外侧（PL）束的ACL。这种方法的基本原理是更多的解剖移植将导致更好的膝关节力学，这是改善长期预后所必需的。为了确定解剖前交叉韧带重建是否可以有效地恢复正常的动态膝关节功能，我们将进行一项双盲随机临床试验来比较SB与解剖前交叉韧带重建。本研究的具体目的是确定DB在1)动态膝关节功能和2)临床结果方面是否优于SB ACL重建。我们将随机分配160例孤立性前交叉韧带损伤患者进行SB或DB前交叉韧带重建，随访2年。我们将利用高速双翼x线摄影（准确评估膝关节运动学）和3D成像（MRI和CT，定义关节和软骨形态）的独特组合来表征关节运动学和软骨表面在功能任务中的相互作用。临床结果将包括松弛度、活动范围、功能强度和患者报告的症状、功能和活动。本研究的成功完成将为解剖前交叉韧带重建恢复正常膝关节力学和改善临床结果的有效性提供证据。如果结果显示出该手术的明显益处，那么将为未来的研究建立一个健全的基础，以评估解剖性前交叉韧带重建对长期临床结果和关节健康的益处。

DESCRIPTION (provided by applicant): Anterior cruciate ligament (ACL) reconstruction is the 6th most common orthopaedic procedure. Disruption of the ACL leads to altered knee function and significantly increases the risk for osteoarthritis (OA). Current methods to reconstruct the ACL are generally perceived to be successful; however, several recent meta- analyses have indicated that normal structure and function of the knee is restored only 60% to 70% of the time and 60 to 90% have radiographic evidence of knee OA within 10 to 20 years. Though the causes of post- traumatic OA are almost certainly multifactorial, a significant factor contributing to the increased risk for OA following ACL injury and surgery may be failure to restore normal anatomy and kinematics of the knee. We have previously shown that conventional single-bundle (SB) ACL reconstruction fails to restore normal knee kinematics, leading to altered patterns of joint loading. There is growing support for the theory that cartilage adapts to its local loading environment and abnormal joint loading may play an important role in the development and progression of OA. Our understanding of ACL anatomy has also improved over the last few years, revealing the shortcomings of current surgical techniques to restore anatomy of the ACL. We have developed double-bundle (DB) surgical procedures to restore normal anatomy of the anteromedial (AM) and posterolateral (PL) bundles of the ACL. The underlying principle for this approach is that more anatomical graft placement will lead to better knee mechanics, which are necessary for improved long-term outcome. To determine if anatomic DB ACL reconstruction can effectively restore normal dynamic knee function, we will conduct a double-blind randomized clinical trial to compare SB vs. anatomic DB ACL reconstruction. The specific aims of this study are to determine if DB is better than SB ACL reconstruction in terms of 1) dynamic knee function and 2) clinical outcomes. We will randomly assign 160 subjects with an isolated ACL injury to SB or DB ACL reconstruction and will follow the subjects for 2 years. We will utilize a unique combination of high-speed biplane radiography (for accurate assessment of knee kinematics) and 3D imaging (MRI and CT, to define joint and cartilage morphology) to characterize joint kinematics and cartilage surface interactions during functional tasks. Clinical outcomes will include laxity, range of motion, functional strength and patient-reported symptoms, function and activity. Successful completion of this study will provide evidence of the efficacy of anatomic DB ACL reconstruction for restoring normal knee mechanics and improving clinical outcomes. If the results show a clear benefit of this procedure, then a sound basis will have been established for future studies to assess the benefits of anatomic DB ACL reconstruction on long-term clinical outcomes and joint health. PUBLIC HEALTH RELEVANCE: Current treatments for ACL injury fail to restore normal function of the knee and prevent the development of knee arthritis. The purpose of this study is to evaluate a novel surgical technique designed to restore the normal, double-bundle anatomy of the ACL, to determine if it can better restore normal motion of the knee and lead to improved outcomes in comparison to current methods to reconstruct the ACL. The results of this study may lead to improved recovery after this common injury and lessen the risk for future development of knee arthritis.