Value of Capsular Repair for Latarjet (CAP-LATARJET)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Enrolling

Conditions: Shoulder Pain

Treatments: Procedure: Latarjet technique

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05978362

2022-A02629-34

Details and patient eligibility

About

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

Full 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.

Enrollment: 86 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups

With capsular repair

Experimental group

Description:

This technique consists of inserting the capsule during the operation according to Latarjet.

Treatment:

Procedure: Latarjet technique

Without capsular repair

Active Comparator group

Description:

Latarjet technique without capsular repair

Treatment:

Procedure: Latarjet technique