跳至主要内容
临床试验/NCT02059473
NCT02059473Unknown不适用

Treatment of Small Acute Full-thickness tears-a Prospective Randomised Controlled Trial

University Hospital, Linkoeping2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
Constant-Murley Shoulder Assessment score

研究概览

简要总结

The purpose of this project is to compare operative repair of traumatically torn rotator cuff tendon with physiotherapy in a randomized prospective study.

详细描述

In clinical practice most patients with a traumatic acute rotator cuff tear are treated with operative repair. The results of surgery are in most cases good but there are also good results in the literature from conservative treatment. So far there has been no prospective randomized comparison between the two treatments. When it comes to degenerative non-traumatic tears, level 1 and 2 studies have not been able to show the superiority of surgery.

This study takes place in 2 clinics in Sweden (Linköping and Kalmar). Patients who have no previous shoulder conditions, a trauma to the shoulder and pain and/or inability to lift their arm will undergo magnetic resonance imaging (MRI). If this indicates a full-thickness rotator cuff tear of the cranial part of the rotator cuff the patient will be randomized to surgery or physiotherapy. Surgical intervention is mini-open repair.

Follow-up takes place at 3 months, 6 months and 12 months with patient scores taken by a blinded independent physiotherapist. At 12 months a new MRI is conducted as well.

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

性别
All
接受健康志愿者

入选标准

  • Trauma to the shoulder
  • Full thickness cranial rotator cuff tear
  • Operation possible within 3 months

排除标准

  • 2 or more rotator cuff tendons involved
  • Dislocation
  • Previous shoulder condition (symptomatic osteoarthritis (Gleno-humeral (GH) joint, Acromial-Clavicular (AC) joint), frozen shoulder, instability, tumor)
  • Malignancy
  • Rheumatic disease
  • Inability to understand swedish
  • Substance abuse

结局指标

主要结局

Constant-Murley Shoulder Assessment score

时间窗: Twelve months

次要结局

  • Western Ontario Rotator Cuff score(Twelve months)
  • MRI(Twelve months)

研究者

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

Hanna Bjornsson

PHD, Orthopeadic shouldersurgeon

University Hospital, Linkoeping

研究点 (2)

Loading locations...

相似试验

Treatment of Small Acute Cuff Tears, a Randomized... | 临床试验