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

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.

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Key information

Conditions

Rotator Cuff Tear Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Ambroise Pare, Boulogne-Billancourt, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Functional evolution of patients with a rotator cuff tear

Time frame: at 5 years

Score to the Algo functional Constant score

Secondary outcomes

Assessing the radiological evolution of tenomuscular lesions induced by a rotator cuff tear

Time frame: at 2 years

lesion size measured by RMI
Assessing the radiological evolution of tenomuscular lesions induced by a rotator cuff tear

Time frame: at 5 years

lesion size measured by RMI
Functional evolution of patients with a rotator cuff tear

Time frame: at 2 years

Score to the Algo functional Constant score

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2014
First posted: Jul 29, 2015
Registry last updated: Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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