跳至主要内容
临床试验/NCT03183466
NCT03183466Unknown不适用

Prospective Randomized Clinical Trial of Arthroscopic Repair Versus Debridement for Subscapularis Tendon Tear More Than 1/2 to Entire 1st Facet (Representing 1/3 to More Than 1/3 Tear of Subscapularis Entire Footprint)

Samsung Medical Center2 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2011年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
American Shoulder and Elbow Surgeons' score

研究概览

简要总结

The purpose of this study was to randomly classify the upper third of the subscapularis in 1/2 of the rupture patients as preoperative group (arthroscopic and arthroscopic debridement group) and the difference between clinical and clinical scores.

详细描述

The degree of rupture that is an adaptation of arthroscopic surgery is now known to be about one-third to one-half of a rupture. However, the most controversial case is the one-third to one-half of the upper tear attached to the tendinous portion of the subscapularis. Currently, debridement or repair is under way. But evidence-based studies are lacking and no clear treatment guidelines are available.

研究设计

研究类型
Interventional
主要目的
Treatment

入排标准

性别
All
接受健康志愿者

入选标准

  • Subscapularis tendon tear from more than 1/2 to entire of 1st facet found during routine arthroscopy with 70 degree scope
  • Isolated or combined with Supraspinatus and/or Infraspinatus tear (SS/IS tear less than 3 cm)
  • Combined biceps lesion
  • Combined acromial clavicle (AC) arthritis

排除标准

  • Revision case or previous surgical history of the index shoulder
  • Any open surgery, including open repair of the subscapularis tendon
  • Compensation case
  • Combined severe arthritis of the glenohumeral joint
  • Patient who selects one's own surgical method, i.e. not randomized
  • Infection, tumor, etc

结局指标

主要结局

American Shoulder and Elbow Surgeons' score

时间窗: 2 year postoperatively

Constant score

时间窗: 2 year postoperatively

Korean Shoulder Score (KSS) score

时间窗: 2 year postoperatively

Range of Motion (ROM)

时间窗: 2 year postoperatively

Pain Visual Analogue Scale (PVAS)

时间窗: 2 year postoperatively

次要结局

  • repair integrity analysis using postoperative MRI(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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