Study Stopped
The sponsor, in consultation with the coordinating investigator, decided to stop the study prematurely on 01/10/2025. No patients were enrolled in the study.
French Cohort of Patients With Rotator Cuff Lesions
PRO-CUFF
1 other identifier
observational
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2025
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2024
CompletedFirst Posted
Study publicly available on registry
April 17, 2024
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2035
April 1, 2026
March 1, 2026
10.7 years
April 9, 2024
March 27, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Shoulder Pain and Disability Index
Improved shoulder function (evolution of SPADI score, composed of a pain sub-score and a shoulder mobility sub-score ≥ 13 points compared with inclusion)
5 years
European quality of life scale - EQ5D
Improved quality of life (change in EQ5D score ≥ 0.1 points from baseline)
5 years
Study Arms (1)
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.
Interventions
develop an appropriate prescription strategy with a view to improving patients' quality of life in the short, medium and long term in this condition
Eligibility Criteria
The study population will consist of patients recruited during their first consultation for the management of a rotator cuff injury.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2024
First Posted
April 17, 2024
Study Start
April 1, 2025
Primary Completion (Estimated)
December 1, 2035
Study Completion (Estimated)
December 1, 2035
Last Updated
April 1, 2026
Record last verified: 2026-03