跳至主要内容
临床试验/NCT01040065
NCT01040065Unknown不适用

Distal Clavicle Resection of Symptomatic Acromioclavicular Joint Arthritis Combined With Rotator Cuff Tear. Prospective Randomized Trial

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
the presence of acromioclavicular joint tenderness

研究概览

简要总结

The purpose of this study is to determine whether distal clavicle resection is effective treatments in patients with acromioclavicular joint pain accompanied by rotator cuff tear.

详细描述

Today, acromioclavicular joint syndrome is itself rarely a cause for hospital visit, and the need for its treatment is even rarer. In comparison, patients who suffer rotator cuff tear accompanied by shoulder impingement syndrome often complain of acromioclavicular joint pain. However, often patients who complain of severe pain have no positive findings on X-ray or MRI, or any sign of impingement. On the other hand, there are patients with positive findings on X-ray or MRI who have only little pain. Even a patient who in the out-patient-department complained of acromioclavicular joint pain on pressure may feel pain on pressure in the physical exam performed for rotator cuff tear surgery. The opposite is very frequent as well, so it is often different depending on the time and the performer. In the literature, there are some authors who maintain that a distal clavicular resection must be done when surgery is used to treat the impingement syndrome, while on the other hand, there are those who endorse only complaining (an operation to trim the distal clavicle and the protruding part of adjust the plane acromion in order to level their plane), and also those who propose an all or none approach to either perform a distal clavicular resection or not at all. Thus, there are varying opinions depending on the authors; moreover, these are all observational studies, and none report on the rotator cuff tear injury. The authors of this study hypothesize and will prove that since the osteoarthritic change and pain of the acromioclavicular joint is secondary to impingement syndrome, distal clavicular resection on rotator cuff repair surgery will have no long term effect.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • rotator-cuff tear requiring repair
  • acromioclavicular joint tenderness more than moderate(Pain Visual Analogue Scale 4-7)
  • acromioclavicular arthritis(Petersson Grade II-III)

排除标准

  • Arthritic changes of glenohumeral joint
  • Combined infection
  • Mini-open, open procedures
  • Complete subscapularis tear
  • Incomplete repair
  • Neurologic abnormality including axillary nerve
  • Adhesive capsulitis
  • Prior surgery, trauma, or infection on shoulder girdle
  • SLAP lesion or biceps tendon lesion without rotator-cuff tear or impingement syndrome

结局指标

主要结局

the presence of acromioclavicular joint tenderness

时间窗: 2 years

次要结局

  • American Shoulder and Elbow Surgeons score(2 years)

研究者

申办方类型
Other

研究点 (1)

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