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Recruiting NCT05978362

Value of Capsular Repair for Latarjet

No phase Interventional Shoulder Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Latarjet technique.
Who it may be relevant to
Registry conditions: Shoulder Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure Latarjet technique
    Realization of a stop according to Latarjet

Primary outcome measures

  • occurrence of osteoarthritis [Time frame: 10 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

France · 1 center
  • Clinique Maussins-Nollet — Paris

Identifiers

NCT: NCT05978362 · 2022-A02629-34

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗