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临床试验/NCT02510352
NCT02510352已完成不适用

Cohort of Patients With a Symptomatic Rotator Cuff Tear Treated Without Surgical Repair

Centre Hospitalier Universitaire de Saint Etienne12 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2006年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
12
主要终点
Functional evolution of patients with a rotator cuff tear

研究概览

简要总结

In accordance with national guidelines surgical repair of rotator cuff tear is the first-line strategy only in young patients, depending on tear size, fatty infiltration of rotator cuff muscles and articular status. In appropriate situations, a satisfactory result is expected in more than 80% of cases with a very good long-term outcome. On the other hand, the first-line strategy in older patients is conservative as the main objective is the treatment of pain and stiffness of the shoulder which can be achieved at least in the short-term with general and local medications and physiotherapy. In addition, poor prognostic factors such as massive tears and muscle fatty infiltration or atrophy, are more frequently present in those patients, leading to poor results of surgical treatment and a high risk of iterative tear after repair.

Because of a lack of evaluation, there is currently no identified prognostic factor of medical treatment and on the other hand no clinical situation in which a surgical repair is mandatory. Therefore, investigator designed this study as an observatory with the follow up of patients with a symptomatic rotator cuff tear treated conservatively.

详细描述

Patients are regularly monitored in rheumatology consultation at 3 months, 6 months, 1 year, 2 years, 30 months, 3 Years, 42 months, 4 years, 54 months and 5 years supplemented by simple radiological monitoring and an MRI followed by 1 year, 2 years and 5 years.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having a clinical symptoms suggesting a rotator cuff tear.
  • Having a full-thickness tear of the rotator cuff confirmed by MRI.
  • Covered by the Social Security system.

排除标准

  • Being included in another clinical trial with a potential alteration of shoulder pathology management.
  • Having a partial tear of the rotator cuff.
  • Having a single lesion of the bicipital tendon.
  • Having a traumatic tear of the rotator cuff less than 3-month old.
  • Having surgery for rotator cuff tear planned within 3 months.
  • Unable to understand the study protocol.
  • Having a contra-indication to MRI.

结局指标

主要结局

Functional evolution of patients with a rotator cuff tear

时间窗: at 5 years

Score to the Algo functional Constant score

次要结局

  • Assessing the radiological evolution of tenomuscular lesions induced by a rotator cuff tear(at 5 years)
  • Functional evolution of patients with a rotator cuff tear(at 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (12)

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