Clinical Trials Directory

Trials / Completed

CompletedNCT02510352

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

Status
Completed
Phase
Study type
Observational
Enrollment
150 (actual)
Sponsor
Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
Sex
All
Age
50 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2006-04-01
Primary completion
2009-10-01
Completion
2014-10-01
First posted
2015-07-29
Last updated
2015-07-29

Locations

12 sites across 1 country: France

Source: ClinicalTrials.gov record NCT02510352. Inclusion in this directory is not an endorsement.