French Cohort of Patients With Rotator Cuff Lesions

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06371872

Acronym

PRO-CUFF

Enrollment

Registered

2024-04-17

Start date

2025-04-01

Completion date

2035-12-01

Last updated

2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Injuries

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.

Interventions

PROCEDUREtotal 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026