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

描述(申请人提供)：重建前十字韧带(ACL)是第六种最常见的骨科手术。前交叉韧带的破坏会导致膝关节功能的改变，并显著增加患骨关节炎(OA)的风险。目前重建前交叉韧带的方法被普遍认为是成功的；然而，最近的几项荟萃分析表明，膝关节的正常结构和功能只有60%到70%的时间被恢复，60%到90%的人在10到20年内有膝关节骨关节炎的放射学证据。尽管创伤后骨性关节炎的原因几乎可以肯定是多因素的，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未能恢复膝关节的正常解剖和运动学。我们以前已经证明，传统的单束(SB)前交叉韧带重建不能恢复正常的膝关节运动学，导致关节负荷模式的改变。越来越多的人支持软骨与其局部负荷环境相适应的理论，关节负荷异常可能在骨关节炎的发生发展中起重要作用。在过去的几年里，我们对前交叉韧带解剖的了解也有所提高，揭示了目前恢复前交叉韧带解剖的外科技术的不足。我们已经开发了双束(DB)手术程序来恢复前内侧(AM)和后外侧(PL)束的正常解剖。这种方法的基本原则是，更多的解剖植骨放置将导致更好的膝关节力学，这是改善长期结果所必需的。为了确定解剖DB前交叉韧带重建术是否能有效恢复正常的膝关节动态功能，我们将进行一项双盲随机临床试验，比较SB和解剖DB前交叉韧带重建术。这项研究的具体目的是确定在1)动态膝关节功能和2)临床结果方面，DB重建前交叉韧带是否优于SB。我们将160名单纯性前交叉韧带损伤的受试者随机分配到SB或DB前交叉韧带重建术中，并对受试者进行为期2年的随访。我们将利用高速双平面摄影(用于准确评估膝关节运动学)和3D成像(MRI和CT，以定义关节和软骨形态)的独特组合来描述功能性任务中的关节运动学和软骨表面相互作用。临床结果将包括松弛、活动范围、功能强度以及患者报告的症状、功能和活动。这项研究的成功完成将为解剖DB前交叉韧带重建在恢复正常膝关节力学和改善临床结果方面的有效性提供证据。如果结果显示该手术有明显的益处，那么将为未来评估解剖DB前交叉韧带重建对长期临床结果和关节健康的益处的研究奠定良好的基础。 公共卫生相关性：目前对前交叉韧带损伤的治疗未能恢复膝关节的正常功能，阻止膝关节炎的发展。本研究的目的是评估一种新的手术技术，旨在恢复正常的前交叉韧带双束解剖，以确定与目前重建前交叉韧带的方法相比，它是否能更好地恢复膝关节的正常运动并改善预后。这项研究的结果可能会改善这种常见损伤后的康复，并降低未来发展为膝关节炎的风险。

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.