Evaluating capsular repair technique for shoulder instability
Prospective, Multicenter, Randomized Single-blind Study on the Interest of Capsular Repair in the Latarjet Operation
This study is testing a new shoulder surgery technique to see if it helps people with shoulder instability avoid developing arthritis in the long run.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05978362 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of a capsular repair technique combined with the Latarjet procedure in treating shoulder instability. It is a prospective, comparative, longitudinal, randomized, single-blind, multicenter study that will evaluate the occurrence of osteoarthritis through radiographic analysis. The goal is to validate preliminary findings that suggest this approach may reduce the risk of developing osteoarthritis, thereby promoting long-term shoulder health and stability.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with shoulder instability and a high risk of recurrence requiring surgical stabilization.
Not a fit: Patients with a history of shoulder surgery for instability or severe health impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help patients maintain a healthy and pain-free shoulder for a longer duration.
How similar studies have performed: Preliminary results from similar approaches suggest potential benefits, but this specific technique is being validated in this study.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Paris
- Clinique Maussins-Nollet — Paris, France (Recruiting)
Study contacts
- Study coordinator: Geoffroy NOURISSAT, MD
- Email: gnourissat@wanadoo.fr
- Phone: 768513650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.