Prospective, Multicenter, Randomized Single-blind Study on the Interest of Capsular Repair in the Latarjet Operation

GCS Ramsay Santé pour l'Enseignement et la Recherche1 site in 1 country86 target enrollmentOctober 11, 2023

ConditionsShoulder Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Shoulder Pain
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Enrollment: 86
Locations: 1
Primary Endpoint: occurrence of osteoarthritis
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 11, 2023

End Date

December 2034

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Responsible Party

Sponsor

Eligibility Criteria

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.