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临床试验/NCT03200262
NCT03200262Unknown不适用

Analytic and Functional Evaluation After Surgical Treatment Using an Original Arthroscopic Trillat Technique in Patients With Chronic Anterior Shoulder Instability

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Change from maximum muscle torque in patients who have undergone surgical treatment for chronic anterior shoulder instability before and after surgery using the Trillat arthroscopic technique

研究概览

简要总结

The shoulder is the most mobile joint in the body, and the most exposed to the risk of dislocation notably anterior. Chronic instability of the shoulder is frequent after dislocation, and principally affects people who are young and active. It can have major functional repercussions, leading to restricted participation in professional or sports activities, even in everyday life activities.

Surgical stabilisation is the reference treatment for chronic anterior shoulder instability, and has given good results. There are numerous surgical techniques available; the orthopaedists at Dijon CHU now practice the Bristow-Trillat technique under arthroscopy, following many years of reflexion and adaptation.

Rehabilitation following the surgery is essential, notably to recover muscle strength in the shoulder rotator cuff after surgery, which correlates directly with dynamic stability of the joint. At the moment, we do not know the objective evolution of muscle strength after the Trillat arthroscopic technique.

The isokinetic evaluation of muscle strength in the rotator cuff has been validated and is reproducible. It gives objective and reliable values for muscle strength, thus making it possible to guide and to optimise rehabilitation protocols done by patients under the supervision of a physiotherapist, and to estimate time to the return to physical, professional or sports activities, without risk.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
16 Years 至 45 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Persons informed about the research
  • Male or female
  • Age between 16 and 45 years
  • Regular sport activity (leisure or competition)
  • First surgical indication for stabilisation using the Trillat arthroscopic technique
  • Patient operated on using the Trillat arthroscopic technique for chronic anterior shoulder instability in the orthopaedic and trauma unit of Dijon CHU

排除标准

  • Persons without health insurance cover
  • Concomitant, disabling shoulder joint disease inflammatory rheumatism, which could be exacerbated by the tests
  • Associated lesions in the shoulder: rupture of rotator cuff tendons, neurological lesions, bone lesions: fracture of the neck of humerus, of the greater tubercle or the coracoid process
  • Paraplegia and peripheral neurological disease
  • Surgery other than the Trillat arthroscopic technique alone
  • Treatment with the Trillat arthroscopic technique as second line, after failure of the first strategy
  • Contralateral history of dislocation with surgical repair
  • History of disease with excess laxity (collagen disease, Marfan, Elhers-Danlos)
  • History of debilitating pain in the back, elbows or wrists
  • Contra-indication for isokinetic tests
  • Cognitive disorders
  • Major post-operative complications delaying the rehabilitation
  • Early recurrence of dislocation after surgery
  • Post-operative immobilisation protocol not respected

结局指标

主要结局

Change from maximum muscle torque in patients who have undergone surgical treatment for chronic anterior shoulder instability before and after surgery using the Trillat arthroscopic technique

时间窗: Baseline, 3 and 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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