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

项目摘要/摘要 理论基础：前交叉韧带重建术(ACLR)在年轻患者中有较高的失败率。 活跃的个体。ACLR的失败与活动受限、生活质量下降、 社会经济成本和较高的骨关节炎(OA)发病率。外侧关节外肌腱固定术(LET)可 为ACLR提供更大的稳定性；但其对失败率和手术诱导的侧向的影响尚不清楚 OA隔间是一个令人担忧的问题。一项荟萃分析表明，骨-髌腱-骨(BPTB)移植物 提供比腿筋肌腱(HT)更好的稳定性，尽管供区更大 发病率。最近，股四头肌腱(Qt)已经成为一种声称稳定的流行的移植物选择。 对BPTB不明确，但没有供体部位并发症。通过评估一次嫁接是否在 降低失败率并将供体部位发病率降至最低，并通过确定是否增加一个 让我们为减少失败做出贡献，这项研究(稳定性2)阐述了NIAMS的使命 有关治疗和预防关节炎的知识以及美国国立卫生研究院促进健康和 减少残疾。 具体目标： 1.确定移植物类型(QT、BPTB或HT)是否会影响移植物失败率2年 在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， 功能和生活质量，基于绩效的功能测量和回归运动2年后ACLR。 3.确定移植血管类型(QT、BPTB或HT)是否影响与介入相关的比率 ACLR术后2年供区发病率、并发症及不良结局。 4.确定添加特定的移植物类型(QT、BPTB或HT)是否带有或不带有LET 具有成本效益的ACLR方法。 方法：这项研究将包括美国、加拿大和欧洲的21个地点，并随机分配 1200例患者接受QT(/-let)或BPTB(/-let)治疗。随机化将按外科医生、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 由盲人评估者对术后两年进行评估，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；供体部位发病率， 侧关节间隙变窄；以及与失败相关的成本。来自先前执行的超线程的数据/- 设RCT(稳定性1)将与稳定性2数据组合。将在意向治疗之后进行分析 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.