Value of Capsular Repair for Latarjet

Not Applicable

Recruiting

• Conditions: Shoulder Pain

• Registration Number: NCT05978362
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

The purpose of the study is to evaluate the occurrence of osteoarthritis (YES/NO) by radiography.

Detailed Description

This is a prospective, comparative, longitudinal, randomized, single-blind, multicenter study.

This study will validate preliminary results on a technique associating capsular repair with abutment according to Latarjet in the treatment of shoulder instabilities. It may help reduce the risk of osteoarthritis and thus allow patients to maintain a healthy, stable and painless shoulder for longer.

Study Timeline

• Study First Submitted: 2023-07-18
• Study First Submitted QC: 2023-08-04
• Study First Posted: 2023-08-07
• Study Start: 2023-10-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2034-12
• Study Completion: 2034-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Patient, male or female, over the age of 18
• Patient with shoulder instability with risk factors for recurrence (ISIS score > 3), requiring surgical stabilization by abutment
• Affiliated patient or beneficiary of a social security scheme
• Patient having been informed and having given his free, informed and written consent.

Exclusion Criteria

• Patient with history of surgery for instability of the same shoulder
• Patient presenting contraindications to the realization of a postoperative scanner
• Patient whose physical and/or psychological health is severely impaired, which according to the investigator may affect the compliance of the study participant
• Patient participating in another clinical research or in a period of exclusion from another research still in progress at the time of inclusion
• Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
• Pregnant, breastfeeding or parturient woman
• Patient hospitalized without consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
occurrence of osteoarthritis	10 years	Change from occurrence of osteoarthritis (YES/NO) on X-ray at 5 and 10 years, compared to inclusion X-ray using the Samilson-Prieto classification.

Trial Locations

Locations (1)

Clinique Maussins-Nollet; 🇫🇷 Paris, France