Clinical trial NCT02510352: Cohort of Patients With a Symptomatic Rotator Cuff Tear Treated Without Surgical Repair
Official title: Cohort of Patients With a Symptomatic Rotator Cuff Tear Treated Without Surgical Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tear
Keywords: Rotator cuff tear
MRI
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-07-29
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having a full-thickness tear of the rotator cuff confirmed by 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Functional evolution of patients with a rotator cuff tear
timeFrame: at 5 years
Secondary outcomes:
measure: Assessing the radiological evolution of tenomuscular lesions induced by a rotator cuff tear
timeFrame: at 2 years
measure: Assessing the radiological evolution of tenomuscular lesions induced by a rotator cuff tear
timeFrame: at 5 years
measure: Functional evolution of patients with a rotator cuff tear
timeFrame: at 2 years
Other outcomes:
Locations:
city: Boulogne Billancourt
country: France
facility: Hopital Ambroise Pare
city: Grenoble
country: France
facility: Centre de Rhumatologie
city: Grenoble
country: France
facility: Clinique Orthocèdres
city: Issy Les Moulineaux
country: France
facility: Hopital Corentin-Celton
city: Lyon
country: France
facility: Clinique Du Parc
city: Lyon
country: France
facility: Centre Orthopedique Santy
city: Marseille
country: France
facility: Cabinet de Rhumatologie
city: Paris
country: France
facility: Hopital Lariboisiere
city: Paris
country: France
facility: Hopital Cochin
city: Saint Etienne
country: France
facility: Chu de Saint Etienne
city: Strasbourg
country: France
facility: Chu de Strasbourg
city: Tours
country: France
facility: Chu de Tours
Study officials:
affiliation: Centre Hospitalier Universitaire de Saint Etienne
name: Thierry Thomas, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: