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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02510352

Enrollment

150

Registered

2015-07-29

Start date

2006-04-30

Completion date

2014-10-31

Last updated

2015-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tear

Keywords

Rotator cuff tear, MRI

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Assessing the radiological evolution of tenomuscular lesions induced by a rotator cuff tear	at 2 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

Countries

France

Outcome results