French Cohort of Patients With Rotator Cuff Lesions: Changes in Shoulder Function and Quality of Life at 1, 2, 5, 8 and 10 Years, According to Their Care
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rotator Cuff Injuries
- Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Enrollment
- 519
- Locations
- 1
- Primary Endpoint
- Shoulder Pain and Disability Index
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to identify, at 5 years, the clinical and therapeutic factors associated with improvement in shoulder functionality and quality of life in patients with transfixing (total) rotator cuff injuries undergoing treatment.
Detailed Description
This is a non-interventional, prospective, longitudinal, multicentre cohort study. The research procedure involves recruiting patients during their first consultation for the management of a rotator cuff injury. Patients will then be contacted by telephone or e-mail every year to monitor the progress of their disease and their treatment. Patients will be asked to complete self-questionnaires assessing shoulder function, quality of life and satisfaction.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient, male or female, over 18 years of age.
- •Patient with a transfixing (total) rotator cuff lesion confirmed by imaging.
- •A patient who has been informed and has expressed no oral objection to taking part in the research.
- •Patient affiliated to or benefiting from a social security scheme.
Exclusion Criteria
- •Patients over 75 years of age.
- •Patients with a history of shoulder surgery.
- •Patients unable to receive emails and/or answer online questionnaires.
- •Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
Outcomes
Primary Outcomes
Shoulder Pain and Disability Index
Time Frame: 5 years
Improved shoulder function (evolution of SPADI score, composed of a pain sub-score and a shoulder mobility sub-score ≥ 13 points compared with inclusion)
European quality of life scale - EQ5D
Time Frame: 5 years
Improved quality of life (change in EQ5D score ≥ 0.1 points from baseline)