STABILITY 2: ACL Reconstruction +/- Lateral Tenodesis with Patellar vs. Quad Tendon

项目概要/摘要 理由：前十字韧带重建 (ACLR) 因年轻人的高失败率而变得复杂 活跃的个体。 ACLR 失败与活动受限、生活质量降低、生活质量增加有关。 社会经济成本和更高的骨关节炎（OA）发病率。外侧关节外肌腱固定术（LET）可能 为 ACLR 提供更高的稳定性；但是，其对失败率的影响尚不清楚，并且手术引起的侧向 隔间 OA 是一个问题。一项荟萃分析表明，骨-髌骨-肌腱-骨（BPTB）移植物 与腘绳肌腱 (HT) 移植物相比，尽管供体部位更大，但稳定性更好 发病率。最近，股四头肌腱 (QT) 已成为一种流行的移植物选择，声称具有稳定性 与 BPTB 模棱两可，但没有供体部位发病率。通过评估一种移植物是否优于 降低失败率并最大限度地减少供体部位发病率，并确定是否添加 LET 有助于减少失败，这项研究（稳定性 2）阐述了 NIAMS 的使命，即为 与关节炎治疗和预防相关的知识以及 NIH 增强健康和预防疾病的使命 减少残疾。 具体目标： 1. 确定有或没有 LET 的移植物类型（QT、BPTB 或 HT）是否会影响移植物失败率 2 年 ACLR 之后。 2. 为了确定有或没有 LET 的移植物类型（QT、BPTB 或 HT）是否会影响患者报告的症状， 功能和生活质量，基于表现的功能测量和 ACLR 后 2 年后重返运动。 3. 确定有或没有 LET 的移植物类型（QT、BPTB 或 HT）是否会影响干预相关的发生率 ACLR 后 2 年供体部位发病率、并发症和不良后果。 4. 确定添加特定移植物类型（QT、BPTB 或 HT）（带或不带 LET）是否更有效 具有成本效益的 ACLR 方法。 方法：本研究将包括美国、加拿大和欧洲的 21 个地点，并将随机分配 1200 名患者接受 QT ( /- LET) 或 BPTB ( /- LET)。随机分组将按外科医生、性别进行分层 以及半月板的状态。患者将遵循标准化的康复方案。结果将是 由盲法评估员在术后两年内进行评估，包括失败状态、功能 表现、患者报告的功能、生活质量和重返运动；存在供体部位发病率， 外侧关节间隙变窄；以及与失败相关的成本。来自先前执行的 HT 的数据 /- LET RCT（稳定性 1）将与稳定性 2 数据相结合。分析将遵循意向治疗 主要包括混合效应建模。

Project Summary/Abstract Rationale: Anterior cruciate ligament reconstruction (ACLR) is complicated by high failure rates in young active individuals. Failure of ACLR is associated with limited activity, reduced quality of life, increased socioeconomic costs and higher rates of osteoarthritis (OA). A lateral extra-articular tenodesis (LET) may provide greater stability to the ACLR; but, its effect on failure rate is unclear and surgery-induced lateral compartment OA is a concern. A meta-analysis suggests that bone-patellar-tendon-bone (BPTB) grafts provide better stability compared to a hamstring tendon (HT) grafts, albeit with greater donor site morbidity. Recently, the quadriceps tendon (QT) has become a popular graft choice claiming stability equivocal to BPTB but without donor site morbidity. By evaluating whether one graft is superior at reducing failure rates and minimizing donor site morbidity and by determining whether the addition of an LET contributes to reduced failure, this study (STABILITY 2) addresses NIAMS’ mission to contribute to knowledge related to the treatment and prevention of arthritis and NIH’s mission to enhance health and reduce disability. Specific Aims: 1. To determine if graft type (QT, BPTB or HT) with or without a LET affects the rate of graft failure 2 years after ACLR. 2. To determine if graft type (QT, BPTB or HT) with or without a LET affects patient-reported symptoms, function & QOL, performance-based measures of function and return-to-sports 2 years after ACLR. 3. To determine if graft type (QT, BPTB or HT) with or without LET affects rates of intervention-related donor site morbidity, complications and adverse outcomes 2 years after ACLR. 4. To determine if the addition of a particular graft type (QT, BPTB or HT) with or without a LET is a more cost-effective approach to ACLR. Methods: This study will include 21 sites across the USA, Canada, and Europe and will randomly assign 1200 patients to either QT (+/- LET) or BPTB (+/- LET). Randomization will be stratified by surgeon, sex and the status of the meniscus. Patients will follow a standardized rehabilitation protocol. Outcomes will be assessed over two years postoperative by a blinded evaluator and include failure status, functional performance, patient-reported function, quality of life and return-to-sport; presence of donor site morbidity, lateral joint space narrowing; and costs associated with failure. Data from a previously performed HT+/- LET RCT (STABILITY 1) will be combined with STABILITY 2 data. Analyses will follow intention-to-treat and primarily consist of mixed effects modeling.