French Shoulder Instability Surgery Cohort Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7+
SponsorChirurgie Du Sport
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Patients enrolled in the ShoulderCDS cohort by one of the surgeons of the Chirurgie du Sport and meeting eligibility criteria
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Shoulder instability surgery
Procedure/SurgeryShoulder 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 outcomes
1
Return to sport
Return to sport after surgery with the level of return, the type of sport and the delay. Questions regarding the return to sport at 6 months, 1 year, 2 years and every 2 years
Time frame
From the surgey to the end of follow up (20 years)2
Shoulder Instability Surgery - Return to Sport Injury score
The SIRSI (Shoulder Instability - Return to Sport Injury) score is used to assess the patient's psychological readiness and apprehension regarding their return to sport following surgical stabilization of the shoulder. The score ranges from 0% (lowest level of psychological readiness) to 100% (highest level of psychological readiness). Questionnaires are administered at 6 months, 1 year, 2 years, and every 2 years thereafter.
Time frame
From the surgery to the end of follow-up (20 years for each patient).3
Western Ontario Shoulder Instability Index (WOSI)
The WOSI (Western Ontario Shoulder Instability Index) is a validated patient-reported outcome measure used to assess shoulder function, pain, and quality of life in patients with shoulder instability. It consists of multiple domains, including physical symptoms, sports/recreation, lifestyle, and emotions. Scores range from 0 to 2100, with higher scores indicating worse shoulder-related quality of life. Questionnaires are administered at 6 months, 1 year, 2 years, and every 2 years thereafter to monitor long-term functional outcomes.
Time frame
From the surgery to the end of follow-up (20 years per patient).4
Walch-Duplay Score
The Walch-Duplay score is a clinician-administered assessment used to evaluate functional outcomes and stability of the shoulder after surgical stabilization. It includes domains for pain, stability, range of motion, and ability to perform sports or daily activities. Scores range from 0 to 100, with higher scores indicating better shoulder function and stability. Assessments are performed at 6 months, 1 year, 2 years, and every 2 years thereafter to monitor long-term recovery and functional outcomes.
Time frame
From the surgery to the end of follow-up (20 years per patient).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov