A Pilot Cohort Study of Surgical and Non-surgical Management of Rotator Cuff Tears
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 222
- 主要终点
- Veterans Rand VR-12 Quality of Life Score
研究概览
简要总结
This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears.
详细描述
This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears. Pragmatic or effectiveness clinical trials reflect real world settings and thus have greater external generalizability than efficacy trials. The evaluation component in this trial will be three-fold: first, the study team will compare the success of patients undergoing operative versus non-operative management and identify which variables predict success in each group; second, investigators will attempt to predict which patients end up choosing, along with their care giver(s), operative versus non-operative management by examining the predictive capability of a selection of variables; third, investigators will evaluate the clinical research site(s), personnel, and implementation processes for their capability to implement clinical trials with the intent of planning for a future large multi-site clinical trial building on the results of the present study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients over 18 years of age with full-thickness rotator cuff tears eligible for operative repair
排除标准
- •less than 18 years old,
- •non-operative rotator cuff tears,
- •calcific tendonitis, fracture, adhesive capsulitis,
- •severe osteoarthritis of the shoulder,
- •no prior shoulder surgery
结局指标
主要结局
Veterans Rand VR-12 Quality of Life Score
时间窗: 64 weeks
次要结局
未报告次要终点
研究者
Joel Gagnier
Assistant Professor
University of Michigan
