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临床试验/NCT02050087
NCT02050087已完成不适用

The Role of Postoperative Immobilization After Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Non-inferiority Trial

Lovisenberg Diakonale Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2013年10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
120
试验地点
2
主要终点
We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint

研究概览

简要总结

The study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair.

详细描述

Rotator cuff tendon injury ranks among the most prevalent of shoulder disorders causing pain and impaired function, and is a major socioeconomic burden on society. The study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair. Our primary goal is to compare clinical and structural results after rotator cuff repair and to compare a restrictive and an active postoperative rehabilitation protocol. Our secondary goal is to establish guidelines for optimized rehabilitation after rotator cuff repair to ensure the best possible outcome for this large group of patients. Our aim is also to establish guidelines for timing of return to work. The major complications following rotator cuff repair and the current rehabilitation regimens are rotator cuff retears and postoperative stiffness. The information obtained in this study may enable development of targeted, cost-effective treatment and rehabilitation with good, lasting long-term results.

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 (Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • Repairable partial- or full-thickness rotator cuff tear affecting supraspinatus and/or upper infraspinatus tendon -

排除标准

  • Irreparable or incomplete repairable tears of supraspinatus and/or infraspinatus tendon.
  • Large/massive rotator cuff tear. Diabetes mellitus. Systemic inflammatory disorder. Fatty muscle infiltration >grade 2 (Goutallier). Subscapularis tendon tear. Adhesive capsulitis. Concomitant labral repair. Revision repair.

结局指标

主要结局

We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint

时间窗: One year

We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint. We will compare WORC of the early range of motion group to a delayed range of motion group.

次要结局

未报告次要终点

研究者

发起方
Lovisenberg Diakonale Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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