The Impact of Humeral Component Version on Outcomes Following Reverse Total Shoulder Arthroplasty: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Postoperative Internal Range of Motion (ROM)
研究概览
简要总结
The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.
详细描述
Retrospective clinical evidence suggests that increasing humeral component retroversion does not affect measured internal or external rotation, however patients with neutral version may experience better function with daily activities requiring internal rotation compared to those with 30 degrees of retroversion. Prospective data on clinical outcomes comparing different humeral component versions in RTSA is currently lacking. The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing primary reverse total shoulder arthroplasty
- •Diagnosis of cuff tear arthropathy or primary OA with RCT
- •Intact posterior rotator cuff and subscapularis preoperatively, as determined by surgeon-administered physical exam
- •18 years or older
排除标准
- •Revision arthroplasty
- •Diagnosis of rheumatoid arthritis, infection, acute trauma or instability
- •Minors (under 18 years of age)
- •Prior open shoulder surgery
- •Concomitant latissimus dorsi transfer
- •Patients not undergoing a standard of care physical therapy protocol
- •Pregnant, patient-reported
- •Cognitively impaired
研究组 & 干预措施
0 degrees humeral component version
Reverse Total Shoulder Arthroplasty with humeral component positioned in 0 degrees of version
干预措施: 0 degrees humeral component version (Device)
30 degrees humeral component retroversion
Reverse Total Shoulder Arthroplasty with humeral component positioned in 30 degrees of retroversion
干预措施: 30 degrees humeral component retroversion (Device)
结局指标
主要结局
Postoperative Internal Range of Motion (ROM)
时间窗: 2 years
Internal range of motion measurements of the shoulder in degrees
Postoperative External Range of Motion (ROM)
时间窗: 2 years
External range of motion measurements of the shoulder in degrees
次要结局
未报告次要终点
研究者
Michael Wiater
◾Vice Chairman Orthopedic Surgery◾Chief of Shoulder Surgery ◾Program Director, Fellowship in Shoulder and Elbow Surgery ◾Program Director, Orthopaedic Surgery Residency
Corewell Health East