跳至主要内容
临床试验/NCT03021733
NCT03021733已完成不适用

A Pilot Cohort Study of Surgical and Non-surgical Management of Rotator Cuff Tears

University of Michigan0 个研究点目标入组 222 人开始时间: 2012年2月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joel Gagnier

Assistant Professor

University of Michigan

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