Comparison of Surgical Treatment by Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Constant score
研究概览
简要总结
The purpose of this study is to compare treatment benefits from surgical treatment by tendon repair and from physiotherapy for small and medium-sized rotator cuff tears.
详细描述
Surgical treatment by tendon repair or physiotherapy are accepted treatment options for small and medium-sized rotator cuff tears, but have never been compared in randomised, controlled studies.
In this study, patients presenting clinical signs together with imaging findings (MRI and sonography) for a full-thickness rotator cuff tear will be randomly allocated to surgery (tendon repair) or physiotherapy. Outcome measuring will be performed by the Constant score, the self report section of the American Shoulder and Elbow Surgeons score (ASES), the Short Form 36 Health Survey (SF-36) and subscores for shoulder motion, pain, strength and patient satisfaction. Scores will be taken at baseline and after 6 months,1, 2, 5, 10 and 15 years by a blinded assessor. All operated shoulders will be controlled by MRI after one year. Patients with no effect from physiotherapy after at least 15 treatment sessions will be offered secondary surgical treatment, and scoring results from last follow-up before surgery will be carried forward to analysis, according to an intention to treat principle.
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 (Outcomes Assessor)
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
- •Clinical history and imaging findings of a rotator cuff tear
排除标准
- •Presence of other local or systemic diseases influencing on shoulder function
- •History of earlier rotator cuff surgery
- •Medical contraindications for surgery
结局指标
主要结局
Constant score
时间窗: baseline, 6 months, 1, 2, 5, 10, 15 years
次要结局
- Patient satisfaction(1, 2, 5, 10, 15 years)
- self report section of the American Shoulder and Elbow Surgeons score (ASES)(baseline, 6 months, 1, 2, 5, 10, 15 years)
- Short Form 36 Health Survey (SF-36)(baseline, 6 months, 1, 2, 5, 10, 15 years)
研究者
Stefan Moosmayer
MD, PhD
Martina Hansen's Hospital
