Value of Capsular Repair for Latarjet

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

Detailed Description
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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.

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

Conditions
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Shoulder Pain

Intervention / Treatment
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* Procedure: Latarjet technique


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, comparative, longitudinal, randomized single-blind study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With capsular repair<br>This technique consists of inserting the capsule during the operation according to Latarjet. | Procedure: Latarjet technique<br>* Realization of a stop according to Latarjet<br>|
| Active Comparator: Without capsular repair<br>Latarjet technique without capsular repair | Procedure: Latarjet technique<br>* Realization of a stop according to Latarjet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of osteoarthritis | 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. | 10 years |