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临床试验/NCT00852657
NCT00852657已完成不适用

Comparison of Surgical Treatment by Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff

Martina Hansen's Hospital2 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2004年9月1日最近更新:
适应症

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

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

发起方
Martina Hansen's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefan Moosmayer

MD, PhD

Martina Hansen's Hospital

研究点 (2)

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