NCT05978362

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
139mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Oct 2023Dec 2037

First Submitted

Initial submission to the registry

July 18, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 11, 2023

Completed
14.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2037

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2037

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

14.2 years

First QC Date

July 18, 2023

Last Update Submit

May 12, 2026

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

With capsular repair

EXPERIMENTAL

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

Procedure: Latarjet technique

Without capsular repair

ACTIVE COMPARATOR

Latarjet technique without capsular repair

Procedure: Latarjet technique

Interventions

Latarjet techniquePROCEDURE

Realization of a stop according to Latarjet

With capsular repairWithout capsular repair

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Maussins-Nollet

Paris, 75019, France

RECRUITING

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Geoffroy NOURISSAT, MD

CONTACT

768513650gnourissat@wanadoo.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
randomized single-blind study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective, comparative, longitudinal, randomized single-blind study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2023

First Posted

August 7, 2023

Study Start

October 11, 2023

Primary Completion (Estimated)

December 1, 2037

Study Completion (Estimated)

December 1, 2037

Last Updated

May 13, 2026

Record last verified: 2026-05

Locations

FR(1)