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

稳定性 2：ACL 重建/- 髌骨外侧肌腱固定术与股四头肌腱固定术

• 批准号: 10249296
• 负责人: JAMES JOHN IRRGANG
• 金额: $ 63.66万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-17 至 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10249296
• 关键词: Address; Affect; Age-Years; Anterolateral; Arthritis; Athletic Injuries; Autologous Transplantation; Blinded; Bone Transplantation; Canada; Data; Degenerative polyarthritis; Drops; Eligibility Determination; Europe; Failure; Health; Health Care Costs; Individual; Intention; International; Intervention; Joints; Knee; Knee bone; Knowledge; Lateral; Meniscus structure of joint; Meta-Analysis; Methods; Mission; Modeling; Morbidity - disease rate; Multi-Institutional Clinical Trial; Multicenter Studies; National Institute of Arthritis and Musculoskeletal and Skin Diseases; Operative Surgical Procedures; Outcome; Participant; Patient Outcomes Assessments; Patients; Performance; Postoperative Period; Prevention; Procedures; Protocols documentation; Quality of life; Randomized; Rehabilitation therapy; Reporting; Risk; Rotation; Rupture; Site; Sports; Standardization; Surgeon; Surgical Management; Symptoms; Tendon structure; Testing; Time; United States National Institutes of Health; Woman; adverse outcome; anterior cruciate ligament injury; anterior cruciate ligament reconstruction; base; bone; cost; cost effective; disability; follow-up; graft failure; hamstring; high risk; improved; patellar tendon; performance based measurement; preference; primary outcome; quadriceps muscle; randomized trial; recruit; repaired; return to sport; secondary outcome; sex; skeletal; socioeconomics; tendon graft

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.

项目总结/文摘