Value of Capsular Repair for Latarjet

Not Applicable

Recruiting

• Conditions: Shoulder Pain
• Interventions: Procedure: Latarjet technique

• 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

Arm && Interventions

Group	Intervention	Description
With capsular repair	Latarjet technique	This technique consists of inserting the capsule during the operation according to Latarjet.
Without capsular repair	Latarjet technique	Latarjet technique without capsular repair

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