Value of Capsular Repair for Latarjet (CAP-LATARJET)

May 12, 2026 updated by: GCS Ramsay Santé pour l'Enseignement et la Recherche

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75019
        • Recruiting
        • Clinique Maussins-Nollet
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
occurrence of osteoarthritis
Time Frame: 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.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Collaborators

Euraxi Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2023

Primary Completion (Estimated)

December 1, 2037

Study Completion (Estimated)

December 1, 2037

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

August 4, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-A02629-34

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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