French Cohort of Patients With Rotator Cuff Lesions

Rotator Cuff Injuries Clinical Trial

— PRO-CUFF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06371872
• Other study ID #: 2024-A00173-44
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: December 2035

Study information

• Verified date: April 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Geoffroy NOURISSAT, MD
• Phone: 682962953
• Email: gnourissat[@]wanadoo.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 519
• Est. completion date: December 2035
• Est. primary completion date: December 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries

Intervention

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

Locations

Country	Name	City	State
France	Clinique Maussins-Nollet	Paris

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	European quality of life scale - EQ5D	Improved quality of life (change in EQ5D score = 0.1 points from baseline)	5 years