NCT Number: NCT07405827
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.
Interested in participating?
Request Info7 year and older
All sexes
Observational
Paris, Île-de-France Region, 75005, France
Location status: Recruiting
Alain Meyer, MD
SUB_INVESTIGATOR
Alexandre HARDY, MD
CONTACT
Antoine Gerometta, Md
SUB_INVESTIGATOR
Frederic Khiami, Professor
SUB_INVESTIGATOR
Nicolas Lefevre, MD
SUB_INVESTIGATOR
Olivier Grimaud, MD
SUB_INVESTIGATOR
Yoann Bohu, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients undergoing surgical treatment for shoulder instability, including:
Bankart repair (anterior or posterior) Latarjet (Butée) procedure
Exclusion criteria
Patient refusal
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.
Other names: Bankart repair (anterior/posterior), Latarjet (Butée)
Time frame: From the surgery to the end of the study (20years of follow-up for each patient)
Time frame: From the surgey to the end of follow up (20 years)
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 surgery to the end of follow-up (20 years for each patient).
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 per patient).
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).
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).
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.
Time frame: From the surgery to the three day after surgery
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
Time frame: From the surgery to the end of follow-up (20 years per patient).
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
Chirurgie Du Sport
Other
Prospective Follow-up Study of Patients Undergoing Shoulder Instability Surgery
Acronym: ShoulderCDS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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