Subscapularis Repair During Reverse Total Shoulder Arthroplasty: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- The American Shoulder and Elbow Surgeons (ASES) Shoulder Score
研究概览
简要总结
This multi-site study involving Northwestern Medicine, Beaumont Health, and Loyola Medicine seeks to answer the following question: do patients who undergo subscapularis (SSc) repair during reverse total shoulder arthroplasty (RSA) have better post-operative outcomes than patients who do not undergo SSc repair during RSA? The investigators hypothesize that patients who do not undergo SSc repair during RSA have better post-operative outcomes than patients who undergo SSc repair during RSA. This study will address the controversy surrounding SSc repair during RSA via a multi-institutional randomized controlled trial that will compare clinical outcomes of patients who receive SSc repair during RSA to those who do not.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary RSA procedure with repairable (intact) SSc
- •Operation will be performed by a participating surgeon using Zimmer Biomet Comprehensive Reverse Shoulder System implant
- •Diagnosis with imaging of arthropathy with rotator cuff insufficiency
- •Surgical approach: Deltopectoral
- •Fluent English speakers/readers
排除标准
- •Minor (<18 y/o)/vulnerable populations (pregnant women, prisoners, adults unable to consent)
- •Revision surgery
- •Oncologic surgery
- •non-ZB CRSS implants
- •Unrepairable SSc
研究组 & 干预措施
Subscapularis repair
Patients will undergo standard of care reverse total shoulder arthroplasty with subscapularis repair
干预措施: Subscapularis repair (Procedure)
No repair
Patients will undergo standard of care reverse total shoulder arthroplasty. The subscapularis will not be repaired.
结局指标
主要结局
The American Shoulder and Elbow Surgeons (ASES) Shoulder Score
时间窗: up to 12 months post-surgery
Scored from 0 (worst shoulder condition) to 100 (best shoulder condition)
次要结局
- Internal Rotator (IR) Strength(up to 12 months post-surgery)
- PROMIS Bank v1.1 - Pain Interference(up to 12 months post-surgery)
- Shoulder Range of Motion(up to 12 months post-surgery)
研究者
Guido Marra
Professor of Orthopaedic Surgery
Northwestern University