NCT07405827

Brief Summary

This 20-year cohort study follows patients after shoulder instability surgery to evaluate recurrence rates, long-term functional outcomes, return-to-sport rates, and complications. The goal is to provide insights into the durability and effectiveness of surgical treatment in order to improve patient care.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
438mo left

Started May 2022

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Progress10%
May 2022Apr 2062

Study Start

First participant enrolled

May 1, 2022

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
16.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2042

Expected
20 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2062

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

20 years

First QC Date

February 5, 2026

Last Update Submit

February 5, 2026

Conditions

Keywords

shoulderinstabilitybankart

Outcome Measures

Primary Outcomes (1)

  • Recurrence of dislocation or subluxation of the operated shoulder

    From the surgery to the end of the study (20years of follow-up for each patient)

Secondary Outcomes (7)

  • Return to sport

    From the surgey to the end of follow up (20 years)

  • Shoulder Instability Surgery - Return to Sport Injury score

    From the surgery to the end of follow-up (20 years for each patient).

  • Western Ontario Shoulder Instability Index (WOSI)

    From the surgery to the end of follow-up (20 years per patient).

  • Walch-Duplay Score

    From the surgery to the end of follow-up (20 years per patient).

  • ROWE score

    From the surgery to the end of follow-up (20 years per patient).

  • +2 more secondary outcomes

Interventions

Shoulder instability surgery encompasses procedures aimed at restoring stability to the glenohumeral joint following recurrent dislocations or subluxations. Bankart repair (anterior or posterior) involves reattaching the detached labrum to the glenoid rim and tightening the associated capsulolabral structures to restore joint stability. Latarjet (Butée) procedure consists of transferring the coracoid process with its attached muscles to the anterior glenoid, providing a bony and dynamic restraint to prevent recurrent dislocations. These procedures aim to restore joint stability, improve functional outcomes, and enable safe return to sport. They are selected based on the type, direction, and severity of instability, as well as patient-specific factors.

Also known as: Bankart repair (anterior/posterior), Latarjet (Butée)

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients enrolled in the ShoulderCDS cohort by one of the surgeons of the Chirurgie du Sport and meeting eligibility criteria

You may qualify if:

  • Patients undergoing surgical treatment for shoulder instability, including:
  • Bankart repair (anterior or posterior) Latarjet (Butée) procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chirurgie du Sport

Paris, Île-de-France Region, 75005, France

RECRUITING

Study Officials

  • Alexandre Hardy, MD

    Chirurgie Du Sport

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgeon

Study Record Dates

First Submitted

February 5, 2026

First Posted

February 12, 2026

Study Start

May 1, 2022

Primary Completion (Estimated)

April 30, 2042

Study Completion (Estimated)

April 30, 2062

Last Updated

February 12, 2026

Record last verified: 2026-02

Locations