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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-04-30

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rotator Cuff Tear

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rotator cuff tear

patients with a symptomatic rotator cuff tear treated without surgical repair

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No