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

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02510352
• Other study ID #: 0501079
• Secondary ID: DGOS
• Status: Completed
• Phase: N/A
• First received: July 24, 2015
• Last updated: July 27, 2015
• Start date: April 2006
• Est. completion date: October 2014

Study information

• Verified date: July 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2014
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rotator Cuff Tear

Locations

Country	Name	City	State
France	Hopital Ambroise Pare	Boulogne Billancourt
France	Centre de Rhumatologie	Grenoble
France	Clinique Orthocèdres	Grenoble
France	Hopital Corentin-Celton	Issy Les Moulineaux
France	Centre Orthopedique Santy	Lyon
France	Clinique Du Parc	Lyon
France	Cabinet de Rhumatologie	Marseille
France	Hopital Cochin	Paris
France	Hopital Lariboisiere	Paris
France	Chu de Saint Etienne	Saint Etienne
France	Chu de Strasbourg	Strasbourg
France	Chu de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional evolution of patients with a rotator cuff tear	Score to the Algo functional Constant score	at 5 years	Yes
Secondary	Assessing the radiological evolution of tenomuscular lesions induced by a rotator cuff tear	lesion size measured by RMI	at 2 years	Yes
Secondary	Assessing the radiological evolution of tenomuscular lesions induced by a rotator cuff tear	lesion size measured by RMI	at 5 years	Yes
Secondary	Functional evolution of patients with a rotator cuff tear	Score to the Algo functional Constant score	at 2 years	Yes