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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 2009

Detailed Description

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.

Arms, Groups and Cohorts

  • Rotator cuff tear
    • patients with a symptomatic rotator cuff tear treated without surgical repair

Clinical Trial Outcome Measures

Primary Measures

  • Functional evolution of patients with a rotator cuff tear
    • Time Frame: at 5 years
    • Score to the Algo functional Constant score

Secondary Measures

  • Assessing the radiological evolution of tenomuscular lesions induced by a rotator cuff tear
    • Time Frame: at 2 years
    • lesion size measured by RMI
  • Assessing the radiological evolution of tenomuscular lesions induced by a rotator cuff tear
    • Time Frame: at 5 years
    • lesion size measured by RMI
  • Functional evolution of patients with a rotator cuff tear
    • Time Frame: at 2 years
    • Score to the Algo functional Constant score

Participating in This Clinical Trial

Inclusion Criteria

  • 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. Exclusion Criteria:

  • 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.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Saint Etienne
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Thierry Thomas, MD PhD, Principal Investigator, Centre Hospitalier Universitaire de Saint Etienne

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