CAP-LATARJET: Value of Capsular Repair for Latarjet

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05978362

Collaborator

(none)

Enrollment

Location

Arms

136

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Shoulder Pain	Procedure: Latarjet technique	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective, comparative, longitudinal, randomized single-blind studyprospective, comparative, longitudinal, randomized single-blind study

Masking:

Single (Participant)

Masking Description:

randomized single-blind study

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2034

Anticipated Study Completion Date :

Dec 1, 2034

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

occurrence of osteoarthritis [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique Maussins-Nollet	Paris		France	75019

Sponsors and Collaborators

GCS Ramsay Santé pour l'Enseignement et la Recherche

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

GCS Ramsay Santé pour l'Enseignement et la Recherche

ClinicalTrials.gov Identifier:

NCT05978362

Other Study ID Numbers:

2022-A02629-34

First Posted:

Aug 7, 2023

Last Update Posted:

Aug 7, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Shoulder Pain

Study Results

No Results Posted as of Aug 7, 2023