search
Back to results

Value of Capsular Repair for Latarjet (CAP-LATARJET)

Primary Purpose

Shoulder Pain

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Latarjet technique
Sponsored by
GCS Ramsay Santé pour l'Enseignement et la Recherche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Clinique Maussins-NolletRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

With capsular repair

Without capsular repair

Arm Description

This technique consists of inserting the capsule during the operation according to Latarjet.

Latarjet technique without capsular repair

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 18, 2023
Last Updated
October 13, 2023
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
search

1. Study Identification

Unique Protocol Identification Number
NCT05978362
Brief Title
Value of Capsular Repair for Latarjet
Acronym
CAP-LATARJET
Official Title
Prospective, Multicenter, Randomized Single-blind Study on the Interest of Capsular Repair in the Latarjet Operation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2023 (Actual)
Primary Completion Date
December 2034 (Anticipated)
Study Completion Date
December 2034 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, comparative, longitudinal, randomized single-blind study
Masking
Participant
Masking Description
randomized single-blind study
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
With capsular repair
Arm Type
Experimental
Arm Description
This technique consists of inserting the capsule during the operation according to Latarjet.
Arm Title
Without capsular repair
Arm Type
Active Comparator
Arm Description
Latarjet technique without capsular repair
Intervention Type
Procedure
Intervention Name(s)
Latarjet technique
Intervention Description
Realization of a stop according to Latarjet
Primary Outcome Measure Information:
Title
occurrence of osteoarthritis
Description
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.
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geoffroy NOURISSAT, MD
Phone
768513650
Ext
+33
Email
gnourissat@wanadoo.fr
Facility Information:
Facility Name
Clinique Maussins-Nollet
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geoffroy NOURISSAT, MD
Phone
768513650
Ext
+33
Email
gnourissat@wanadoo.fr

12. IPD Sharing Statement

Learn more about this trial

Value of Capsular Repair for Latarjet

We'll reach out to this number within 24 hrs