跳至主要内容
临床试验/NCT02943005
NCT02943005Unknown不适用

Post-operative Mobilisation After Rotator Cuff Repair: Sling Versus Nothing. A Randomized Prospective Study.

La Tour Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年9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
80
试验地点
2
主要终点
ASES score

研究概览

简要总结

The aim of this study is to compare rehabilitation with the wearing of a sling, to rehabilitation without any immobilization after an arthroscopic repair of the supraspinatus tendon. The goal is to offer to patients a simplified rehabilitation management, with a faster recovery, less pain and a quicker return to normal life.

详细描述

Rotator cuff tear is a frequent problem, increasing with age1. Thus arthroscopic repair is a frequent surgery. Despite this important number of cuff repair, the re-tear rate varies from 20 to 90% depending on tear severity and type of repair1,2. Many factors are implicated in tendon healing and post-operative clinical results. Some are unchangeable (age, tear size, chronicity...) but some are under the surgeon control like the surgical technique and the post-operative rehabilitation protocol. It exists many surgical repair techniques6, 7, with a massive development of technology during the last twenty years. However in terms of rehabilitation, there is only few studies and evidence of best practices4. The main aspect on which the surgeon can act, is the immobilization time. Actually, standard protocols include an immobilisation of 4 to 6 weeks before physiotherapy beginning5.

A recent review of the literature3 has highlighted five studies comparing different rehabilitation protocols, which include different immobilization periods ranging from 0 to 8 weeks, and different types of mobilization (under physiotherapist supervision or not, with machine or not). They found a similar rate of re-tear between the different protocols. But early passive motion enables to improve the range of motion during first 3-6 months, with similar results at one year.

However in all these studies, all patients had to wear a sling for at least 4 weeks, even in the early mobilization group. But the investigators don't know if this sling is really useful, probably not if the investigators follow the logic of faster recovery and same long term results with early mobilization. At our best knowledge, no study has sought to compare the usefulness of sling wearing after a rotator cuff repair. Removing sling could simplify rehabilitation and should provide a return to normal function faster, with greater satisfaction and a similar rate of re-tear.

The aim of this study is to compare rehabilitation with the wearing of a sling, to rehabilitation without any immobilization after an arthroscopic repair of the supraspinatus tendon.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 18 years old
  • Small tear (< 3cm) of the supraspinatus tendon
  • Arthroscopic cuff repair

排除标准

  • Lesion of the anterior or posterior rotator cuff
  • Significant other trauma of the involved upper member (e.g. associated scapular or clavicular fractures, acromioclavicular dislocation)
  • Preoperative shoulder stiffness
  • Inability to follow properly post-surgery recommendations.

结局指标

主要结局

ASES score

时间窗: 3 months

Clinical score (0-100)

次要结局

  • Retear or non healing of the rotator cuff(6 months)

研究者

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

Adrien Schwitzguebel

Investigator

La Tour Hospital

研究点 (2)

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