Shoulder Instability Subluxation BilateralShoulderCDSNCT07405827
French Shoulder Instability Surgery Cohort Study
An observational study of Shoulder Instability Subluxation Bilateral and Shoulder Instability, run by Chirurgie Du Sport at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Shoulder Instability Subluxation Bilateral, Shoulder Instability
- What is being tested?
- Shoulder instability surgery
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2022to 30 Apr 2062
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients enrolled in the ShoulderCDS cohort by one of the surgeons of the Chirurgie du Sport and meeting eligibility criteria
Who may be able to join
- Patients undergoing surgical treatment for shoulder instability, including:
- Bankart repair (anterior or posterior) Latarjet (Butée) procedure
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chirurgie du Sport
Paris, Île-de-France Region, 75005
Alexandre HARDY, MD, 0615101016, alexandre.hardy@me.com
Nicolas Lefevre, MD
About this study
Official title: 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.
Read the 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.
- Being tested
- Shoulder instability surgery
- Keywords
- shoulder, instability, bankart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder instability surgeryProcedure or surgery
Also called Bankart repair (anterior/posterior), Latarjet (Butée)
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of dislocation or subluxation of the operated shoulder
Measured: From the surgery to the end of the study (20years of follow-up for each patient)
Secondary outcomes (7)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: From the surgery to the end of follow-up (20 years per patient).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 May 2022
- Primary completion30 Apr 2042 (estimated)
- Study completion30 Apr 2062 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Instability Subluxation BilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Chirurgie Du Sport
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HARDY Alexandre, Chirurgie Du Sport
- Investigators
- Alexandre Hardy, MD, Principal investigator, Chirurgie Du Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405827
- Sponsor's protocol ID
- ShoulderCDS
- Acronym
- ShoulderCDS
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Follow-up Study of Patients Undergoing Shoulder Instability Surgery
- ClinicalTrials.gov ID
- NCT07405827
- Acronym / sponsor ID
- ShoulderCDS / ShoulderCDS
- Keywords
- shoulder, instability, bankart
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Chirurgie Du SportUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Apr 2042 (estimated)
- Study completion
- 30 Apr 2062 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients enrolled in the ShoulderCDS cohort by one of the surgeons of the Chirurgie du Sport and meeting eligibility criteria
Key inclusion criteria (2 listed)
- Bankart repair (anterior or posterior) Latarjet (Butée) procedure
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shoulder instability surgeryAlso: Bankart repair (anterior/posterior), Latarjet (Butée)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. | Procedure or surgery | – |
Primary outcome
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)
7 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandre Hardy, MD principal investigator
Chirurgie Du Sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Instability Subluxation Bilateral and Shoulder Instability, run by Chirurgie Du Sport at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026; AzTrials last refreshed its copy on 29 Oct 2026.