French Cohort of Patients With Rotator Cuff Lesions (PRO-CUFF)
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
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Contacts and Locations
Study Locations
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Paris, France, 75019
- Clinique Maussins-Nollet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patients with rotator cuff injuries
Patients will be recruited during their first consultation for treatment 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. These questionnaires will be accessible via a secure website. |
develop an appropriate prescription strategy with a view to improving patients' quality of life in the short, medium and long term in this condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
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5 years
|
|
European quality of life scale - EQ5D
Time Frame: 5 years
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Improved quality of life (change in EQ5D score ≥ 0.1 points from baseline)
|
5 years
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-A00173-44
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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