French Cohort of Patients With Rotator Cuff Lesions

Not yet recruiting

• Conditions: Rotator Cuff Injuries
• Interventions: Procedure: total transfixing injury to the rotator cuff

• Registration Number: NCT06371872
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

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.

Study Timeline

• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Study Start: 2025-04
• Primary Completion: 2035-12
• Study Completion: 2035-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 519

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with rotator cuff injuries	total transfixing injury to the rotator cuff	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.

Primary Outcome Measures

Name	Time	Method
Shoulder Pain and Disability Index	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	5 years	Improved quality of life (change in EQ5D score ≥ 0.1 points from baseline)

Trial Locations

Locations (1)

Clinique Maussins-Nollet; 🇫🇷 Paris, France