French Cohort of Patients With Rotator Cuff Lesions (PRO-CUFF)

March 27, 2026 updated by: GCS Ramsay Santé pour l'Enseignement et la Recherche

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

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.

Study Overview

Status

Withdrawn

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

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Clinique Maussins-Nollet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of patients recruited during their first consultation for the management of a rotator cuff injury.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Procedure: total transfixing injury to the rotator cuff
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)
5 years
European quality of life scale - EQ5D
Time Frame: 5 years
Improved quality of life (change in EQ5D score ≥ 0.1 points from baseline)
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Collaborators

Euraxi Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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