French Cohort of Patients With Rotator Cuff Lesions: Changes in Shoulder Function and Quality of Life at 1, 2, 5, 8 and 10 Years, According to Their Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 519
- 试验地点
- 1
- 主要终点
- Shoulder Pain and Disability Index
研究概览
简要总结
The purpose of this study is to identify, at 5 years, the clinical and therapeutic factors associated with improvement in shoulder functionality and quality of life in patients with transfixing (total) rotator cuff injuries undergoing treatment.
详细描述
This is a non-interventional, prospective, longitudinal, multicentre cohort study.
The research procedure involves recruiting patients during their first consultation for the management of a rotator cuff injury. Patients will then be contacted by telephone or e-mail every year to monitor the progress of their disease and their treatment. Patients will be asked to complete self-questionnaires assessing shoulder function, quality of life and satisfaction.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient, male or female, over 18 years of age.
- •Patient with a transfixing (total) rotator cuff lesion confirmed by imaging.
- •A patient who has been informed and has expressed no oral objection to taking part in the research.
- •Patient affiliated to or benefiting from a social security scheme.
排除标准
- •Patients over 75 years of age.
- •Patients with a history of shoulder surgery.
- •Patients unable to receive emails and/or answer online questionnaires.
- •Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
结局指标
主要结局
Shoulder Pain and Disability Index
时间窗: 5 years
Improved shoulder function (evolution of SPADI score, composed of a pain sub-score and a shoulder mobility sub-score ≥ 13 points compared with inclusion)
European quality of life scale - EQ5D
时间窗: 5 years
Improved quality of life (change in EQ5D score ≥ 0.1 points from baseline)
次要结局
未报告次要终点