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

Completed

• Conditions: Rotator Cuff Tear

• Registration Number: NCT02510352
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

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.

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2009-10
• Study Completion: 2014-10
• Status Verified: 2015-07
• Study First Submitted: 2015-07-24
• Study First Submitted QC: 2015-07-27
• Last Update Submitted: 2015-07-27
• Study First Posted: 2015-07-29
• Last Update Posted: 2015-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (12)

Chu de Tours; 🇫🇷 Tours, France

Hopital Ambroise Pare; 🇫🇷 Boulogne Billancourt, France

Clinique Orthocèdres; 🇫🇷 Grenoble, France

Hopital Corentin-Celton; 🇫🇷 Issy Les Moulineaux, France

Centre Orthopedique Santy; 🇫🇷 Lyon, France

Hopital Lariboisiere; 🇫🇷 Paris, France

Hopital Cochin; 🇫🇷 Paris, France

Clinique Du Parc; 🇫🇷 Lyon, France

Cabinet de Rhumatologie; 🇫🇷 Marseille, France

Chu de Saint Etienne; 🇫🇷 Saint Etienne, France

Chu de Strasbourg; 🇫🇷 Strasbourg, France

Centre de Rhumatologie; 🇫🇷 Grenoble, France