Graft Reconstruction for Irreparable Rotator Cuff Tears: Superior Capsule Reconstruction or Tendon Repair With Graft Interposition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- American Shoulder and Elbow Surgeon Outcome - patient portion
研究概览
简要总结
Randomized controlled trial examining superior capsule reconstruction versus tendon repair with graft interposition in "irreparable" rotator cuff tears.
详细描述
RCT n = 50
Groups:
- bridging
- SCR
Outcomes:
- WORC
- ASES
- QuickDASH
- MRI at 12 months post-op
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participant and research assistant collecting outcomes were blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Large to massive rotator cuff tear (with or without subscapularis tear) that may possibly be irreparable without the use of graft materials (confirmed intra-operatively)
- •Either primary tear or re-tear after previous repair
- •Radiographic evidence of Hamada stage 1-3, with or without Samilson & Prieto mild osteoarthritis (<3mm inferior osteophyte)
排除标准
- •Primary glenohumeral osteoarthritis: radiographic evidence of Samilson & Prieto classification moderate or greater
- •Cuff tear arthropathy (CTA): radiographic evidence of Hamada stage 4 or above
- •Inflammatory joint disease of the shoulder (e.g. rheumatoid arthritis)
- •Medical issues precluding surgery
- •Unwilling or unable to complete study outcomes
- •Worker's Compensation Claim or litigation
研究组 & 干预措施
Bridging
Tendon repair with graft interposition
干预措施: Bridging (Procedure)
SCR
Superior Capsule reconstruction
干预措施: SCR (Procedure)
结局指标
主要结局
American Shoulder and Elbow Surgeon Outcome - patient portion
时间窗: 3 months
American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)
American Shoulder and Elbow Surgeon Outcome - patient portion
时间窗: 24 months
American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)
American Shoulder and Elbow Surgeon Outcome - patient portion
时间窗: 12 months
American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)
American Shoulder and Elbow Surgeon Outcome - patient portion
时间窗: 6 months
American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)
次要结局
- Tendon healing, assessed via MRI(12 months)
- Western Ontario Rotator Cuff Index(3 months)
- Disabilities of the Arm, Shoulder and Hand - QuickDASH(3 months)
- Western Ontario Rotator Cuff Index(24 months)
- Western Ontario Rotator Cuff Index(12 months)
- Western Ontario Rotator Cuff Index(6 months)
- Disabilities of the Arm, Shoulder and Hand - QuickDASH(24 months)
- Disabilities of the Arm, Shoulder and Hand - QuickDASH(12 months)
- Disabilities of the Arm, Shoulder and Hand - QuickDASH(6 months)