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

项目概要/摘要 理由：前交叉韧带重建（ACLR）在年轻人中失败率高 积极的个人。ACLR失败与活动受限、生活质量降低、 社会经济成本和骨关节炎（OA）的发病率更高。外侧关节外肌腱固定术（LET）可以 为ACLR提供更大的稳定性;但是，其对失效率的影响尚不清楚，并且手术引起的侧向 隔室OA是一个问题。一项荟萃分析表明，骨-髌腱-骨（BPTB）移植物 与腘绳肌腱（HT）移植物相比，提供了更好的稳定性，尽管供体部位更大 发病率最近，股四头肌腱（QT）已成为一个流行的移植选择声称稳定 与BPTB不明确，但无供区发病率。通过评估一个移植物是否在上级 降低失败率和最小化供体部位发病率，并通过确定是否添加 LET有助于减少故障，本研究（稳定性2）解决了NIAMS的使命， 与关节炎的治疗和预防相关的知识和NIH的使命，以提高健康和 减少残疾。 具体目标： 1.确定移植物类型（QT、BPTB或HT）伴或不伴LET是否影响2年移植物失效率 ACLR之后。 2.为了确定有或没有LET的移植物类型（QT、BPTB或HT）是否影响患者报告的症状， 功能和QOL，基于性能的功能测量和ACLR后2年恢复运动。 3.确定移植物类型（QT、BPTB或HT）伴或不伴LET是否影响介入相关的发生率 ACLR后2年供区发病率、并发症和不良结局。 4.为了确定添加特定的移植物类型（QT、BPTB或HT），有或没有LET， ACLR的成本效益方法。 方法：本研究将包括美国、加拿大和欧洲的21个研究中心，并将随机分配 1200例患者接受QT（+/- LET）或BPTB（+/- LET）。随机化将按外科医生、性别分层 以及弯月面的状态。患者将遵循标准化的康复方案。成果将 由设盲评价者在术后2年内进行评估，包括失效状态、功能 性能、患者报告的功能、生活质量和恢复运动;供体部位发病率的存在， 外侧关节间隙变窄;以及与失败相关的成本。数据来自先前进行的HT+/- LET RCT（稳定性1）将与稳定性2数据合并。分析将遵循意向治疗 并且主要包括混合效果建模。

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.