French Shoulder Instability Surgery Cohort Study (ShoulderCDS)

Prospective Follow-up Study of Patients Undergoing Shoulder Instability Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Instability; Shoulder Instability Subluxation Bilateral
• Intervention / Treatment: Procedure: Shoulder instability surgery

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.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

Study Locations

• France
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75005
      • Recruiting
      • Chirurgie du Sport
      • Contact: Alexandre HARDY, MD; Phone Number: 0615101016; Email: alexandre.hardy@me.com
      • Sub-Investigator: Nicolas Lefevre, MD
      • Sub-Investigator: Yoann Bohu, MD
      • Sub-Investigator: Antoine Gerometta, MD
      • Sub-Investigator: Olivier Grimaud, MD
      • Sub-Investigator: Alain Meyer, MD
      • Sub-Investigator: Frederic Khiami, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria

Patients undergoing surgical treatment for shoulder instability, including:

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

Exclusion Criteria Patient refusal

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From the surgey to the end of follow up (20 years)
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.	From the surgery to the end of follow-up (20 years for each patient).
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.	From the surgery to the end of follow-up (20 years per patient).
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.	From the surgery to the end of follow-up (20 years per patient).
ROWE score	The Rowe score is a clinician-administered assessment used to evaluate shoulder stability, function, and pain following surgical treatment for shoulder instability. It includes components for stability, motion, and functional ability, with a total score ranging from 0 to 100, where higher scores indicate better shoulder function and stability. Assessments are performed at 6 months, 1 year, 2 years, and every 2 years thereafter to monitor long-term outcomes.	From the surgery to the end of follow-up (20 years per patient).
Visual Analogue Scale	The VAS score (Visual Analogue Scale) is a simple and widely used method for assessing subjective experiences, such as pain intensity, fatigue, or discomfort. It typically consists of a horizontal or vertical line, usually 10 cm in length, with endpoints representing the extremes of the experience being measured: 0: "No pain" (or "no discomfort"). 10: "Worst pain imaginable" (or "maximum discomfort") Evaluated during the 3 first days after surgery	From the surgery to the three day after surgery
Complications	Complications of the surgery and any re-operations will be recorded, including: Removal of hardware Infection Hematoma Revision shoulder stabilization Cartilage surgery Arthrodesis Shoulder prosthesis	From the surgery to the end of follow-up (20 years per patient).

Collaborators and Investigators

• Sponsor: Chirurgie Du Sport
• Investigators: Principal Investigator: Alexandre Hardy, MD, Chirurgie du Sport

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): April 30, 2042
• Study Completion (Estimated): April 30, 2062

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: instability; shoulder; bankart
• Other Study ID Numbers: ShoulderCDS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No