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

单束与双束 ACL 重建：前瞻性随机试验

• 批准号: 8115028
• 负责人: Freddie H Fu
• 金额: $ 53.58万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-01 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8115028
• 关键词: Address; Anatomy; Anterior Cruciate Ligament; Arthritis; Articular Range of Motion; Cartilage; Clinical; Complex; Degenerative polyarthritis; Development; Diagnostic radiologic examination; Double-Blind Method; Environment; Failure; Future; Goals; Health; Humulus; Injury; Joints; Knee; Knee Osteoarthritis; Knee joint; Lateral; Lead; Limb structure; Magnetic Resonance Imaging; Measures; Mechanics; Meta-Analysis; Methods; Morphology; Motion; Operative Surgical Procedures; Orthopedic Procedures; Outcome; Outcome Measure; Patients; Pattern; Play; Procedures; Randomized; Randomized Clinical Trials; Recovery; Reporting; Research; Risk; Role; Speed; Sports; Structure; Surface; Symptoms; Techniques; Testing; Three-Dimensional Imaging; Time; United States; anterior cruciate ligament reconstruction; base; cohort; design; follow-up; functional outcomes; functional restoration; improved; joint function; joint loading; kinematics; ligament injury; novel; patient oriented; prevent; prospective; public health relevance; randomized trial; reconstruction; restoration; sound; stereoradiography; theories

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.

描述（由申请人提供）：前交叉韧带（ACL）重建是第六常见的骨科手术。ACL的破坏导致膝关节功能改变，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Meta分析表明，膝关节的正常结构和功能仅在60%至70%的时间内恢复，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OA的原因几乎肯定是多因素的，但导致ACL损伤和手术后OA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结构和运动学。我们之前已经证明，传统的单束（SB）ACL重建无法恢复正常的膝关节运动学，导致关节负荷模式改变。越来越多的人支持软骨适应其局部负荷环境的理论，并且异常关节负荷可能在OA的发展和进展中起重要作用。在过去的几年里，我们对ACL解剖结构的理解也有所提高，揭示了当前手术技术在恢复ACL解剖结构方面的缺点。我们开发了双束（DB）外科手术，以恢复ACL前内侧（AM）和后外侧（PL）束的正常解剖结构。这种方法的基本原理是，更多的解剖移植物放置将导致更好的膝关节力学，这是改善长期结局所必需的。为了确定解剖DB ACL重建是否可以有效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，以比较SB与解剖DB ACL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）临床结局方面是否优于SB ACL重建。我们将随机分配160例单独ACL损伤的受试者进行SB或DB ACL重建，并对受试者进行2年随访。我们将利用高速双平面X线摄影（用于准确评估膝关节运动学）和3D成像（MRI和CT，用于定义关节和软骨形态）的独特组合来表征功能任务期间的关节运动学和软骨表面相互作用。临床结局将包括松弛度、活动度、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DB ACL解剖重建术恢复正常膝关节力学和改善临床结局的有效性提供证据。如果结果显示该手术的明显受益，则将为未来的研究建立良好的基础，以评估解剖DB ACL重建对长期临床结局和关节健康的受益。 公共卫生相关性：目前ACL损伤的治疗无法恢复膝关节的正常功能，也无法预防膝关节炎的发展。本研究的目的是评价一种旨在恢复ACL正常双束解剖结构的新型手术技术，以确定与当前重建ACL的方法相比，该技术是否能更好地恢复膝关节的正常运动并改善结局。这项研究的结果可能会改善这种常见损伤后的恢复，并降低未来膝关节炎发展的风险。