Value of Capsular Repair for Latarjet

NCT ID: NCT05978362

Last Updated: 2025-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-11

Study Completion Date

2034-12-31

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.

Conditions

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Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, comparative, longitudinal, randomized single-blind study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
randomized single-blind study

Study Groups

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With capsular repair

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

Group Type EXPERIMENTAL

Latarjet technique

Intervention Type PROCEDURE

Realization of a stop according to Latarjet

Without capsular repair

Latarjet technique without capsular repair

Group Type ACTIVE_COMPARATOR

Latarjet technique

Intervention Type PROCEDURE

Realization of a stop according to Latarjet

Interventions

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Latarjet technique

Realization of a stop according to Latarjet

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Euraxi Pharma

INDUSTRY

Sponsor Role collaborator

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique Maussins-Nollet

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Geoffroy NOURISSAT, MD

Role: CONTACT

768513650 ext. +33

Facility Contacts

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Geoffroy NOURISSAT, MD

Role: primary

768513650 ext. +33

Other Identifiers

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2022-A02629-34

Identifier Type: -

Identifier Source: org_study_id

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