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
- 4
- 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
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