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Recruiting NCT07405827

French Shoulder Instability Surgery Cohort Study

Observational Shoulder Instability Subluxation Bilateral Shoulder Instability

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Shoulder instability surgery.
Who it may be relevant to
Registry conditions: Shoulder Instability Subluxation Bilateral, Shoulder Instability. Basic parameters: from 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prospective Follow-up Study of Patients Undergoing Shoulder Instability Surgery

Overview

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.

Detailed description

This study is a long-term cohort analysis involving patients who have undergone shoulder instability surgery. The goal is to follow these patients over a 20-year period to assess several important outcomes. Specifically, the study aims to evaluate the rate of recurrence, the rates and quality of return to sport, long-term functional outcomes using validated scoring systems, and the incidence of complications related to the procedure.

By collecting detailed and consistent data over two decades, the research seeks to provide valuable insights into the durability and effectiveness of surgical treatment for shoulder instability, contributing to a better understanding and improved care for patients.

Interventions

  • Procedure Shoulder instability surgery
    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 restra

Primary outcome measures

  • Recurrence of dislocation or subluxation of the operated shoulder [Time frame: From the surgery to the end of the study (20years of follow-up for each patient)]
Secondary outcome measures (7)
  • Return to sport [Time frame: From the surgey to the end of follow up (20 years)]
  • Shoulder Instability Surgery - Return to Sport Injury score [Time frame: From the surgery to the end of follow-up (20 years for each patient).]
  • Western Ontario Shoulder Instability Index (WOSI) [Time frame: From the surgery to the end of follow-up (20 years per patient).]
  • Walch-Duplay Score [Time frame: From the surgery to the end of follow-up (20 years per patient).]
  • ROWE score [Time frame: From the surgery to the end of follow-up (20 years per patient).]
  • Visual Analogue Scale [Time frame: From the surgery to the three day after surgery]
  • Complications [Time frame: From the surgery to the end of follow-up (20 years per patient).]

Eligibility criteria

Inclusion criteria

Patients undergoing surgical treatment for shoulder instability, including:

Bankart repair (anterior or posterior) Latarjet (Butée) procedure

Exclusion Criteria Patient refusal

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Chirurgie du Sport — Paris

Identifiers

NCT: NCT07405827 · ShoulderCDS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗