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临床试验/NCT01557309
NCT01557309已完成不适用

Arthroscopic Repair of Traumatic Rotator Cuff Tears. A Prospective Trial

Helsingborgs Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Western Ontario Rotator Cuff Index (WORC)

研究概览

简要总结

The optimal timing for surgical repair of traumatic rotator cuff tears is controversial. Today there are no prospective studies investigating the short to mid-term outcome after early arthroscopic repair of traumatic rotator cuff tears and the Swedish National Musculoskeletal Competence Centre requests more research to this subject. The investigators will follow 60 patients with acute rotator cuff tear undergoing early rotator cuff repair during the first year after surgery.

The investigators hypothesise that the outcome after rotator cuff repair is good.

详细描述

There exists controversy in the current literature regarding timing for surgical repair of traumatic rotator cuff tears. We have seen no prospective studies describing the progression of shoulder function improvement the first year after arthroscopic rotator cuff repair.

We hypothesize that early arthroscopic repair of traumatic rotator cuff tears yields successful functional and structural outcomes but there will be a progression of shoulder function improvement during the hole first postoperative year.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • trauma to the shoulder with sudden onset of symptoms
  • asymptomatic shoulder before trauma
  • mr positive for full thickness rotator cuff tear

排除标准

  • severe comorbidity
  • more than 6 weeks after trauma
  • glenohumeral degeneration signs or osteoarthritis on x-ray

结局指标

主要结局

Western Ontario Rotator Cuff Index (WORC)

时间窗: Two years

次要结局

  • standardised measure of health status with EQ-5D(Two years)
  • Complications(within one year)
  • Constant Shoulder Score (CS)(One year)
  • cuff integrity(One year)

研究者

发起方
Helsingborgs Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Knut Aagaard, MD

MD.

Lund University

研究点 (1)

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