Value of Capsular Repair for Latarjet | NCT05978362

Studies
Value of Capsular Repair for Latarjet

NCT05978362

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status

Recruiting

Last Update Posted

May 13, 2026Actual

Enrollment

86Estimated

Phase

Not Applicable

Conditions

Shoulder Pain

Interventions

Latarjet technique

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 11, 2023Actual

Primary Completion Date

Dec 2037Estimated

Completion Date

Dec 2037Estimated

First Submitted Date

Jul 18, 2023

First Submission Date that Met QC Criteria

Aug 4, 2023

First Posted Date

Aug 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2026

Last Update Posted Date

May 13, 2026Actual

Name	Class
Euraxi Pharma	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

86Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
With capsular repair	Experimental	This technique consists of inserting the capsule during the operation according to Latarjet.	Procedure: Latarjet technique
Without capsular repair	Active Comparator	Latarjet technique without capsular repair	Procedure: Latarjet technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Latarjet technique	Procedure	Realization of a stop according to Latarjet	With capsular repair Without capsular repair

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D018771	Arthralgia
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D010146	Pain