Value of Capsular Repair for Latarjet

Shoulder Pain Clinical Trial

— CAP-LATARJET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05978362
• Other study ID #: 2022-A02629-34
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2023
• Est. completion date: December 2034

Study information

• Verified date: October 2023
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Geoffroy NOURISSAT, MD
• Phone: 768513650
• Email: gnourissat[@]wanadoo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 2034
• Est. primary completion date: December 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Procedure:
• Latarjet technique
Realization of a stop according to Latarjet

Locations

Country	Name	City	State
France	Clinique Maussins-Nollet	Paris

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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