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

July 27, 2015 updated by: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Overview

Status

Completed

Conditions

Rotator Cuff Tear

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 Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Boulogne Billancourt, France, 92100
    - Hôpital Ambroise Paré
  - Grenoble, France, 38000
    - Centre de Rhumatologie
  - Grenoble, France, 38130
    - Clinique Orthocèdres
  - Issy Les Moulineaux, France, 92130
    - Hôpital Corentin-Celton
  - Lyon, France, 69006
    - Clinique du Parc
  - Lyon, France, 69008
    - Centre Orthopedique Santy
  - Marseille, France, 13006
    - Cabinet de Rhumatologie
  - Paris, France, 75010
    - Hôpital Lariboisière
  - Paris, France, 75014
    - Hôpital Cochin
  - Saint Etienne, France, 42055
    - CHU de Saint Etienne
  - Strasbourg, France, 67000
    - CHU de Strasbourg
  - Tours, France, 37000
    - CHU de Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients having a full-thickness tear of the rotator cuff confirmed by MRI

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Rotator cuff tear patients with a symptomatic rotator cuff tear treated without surgical repair

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

Principal Investigator: Thierry Thomas, MD PhD, Centre Hospitalier Universitaire de Saint Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

July 24, 2015

First Submitted That Met QC Criteria

July 27, 2015

First Posted (Estimate)

July 29, 2015

Study Record Updates

Last Update Posted (Estimate)