Culture Analysis Performed During a Latarjet Anterior Shoulder Stabilization Procedure.

NCT05658211 | Completed

• 1 other identifier: COS-RGDS-2021-06-014
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter study of data from the medical records of patients who underwent shoulder stabilization surgery and who underwent a normally scheduled evaluation as part of their postoperative follow-up six months after surgery.

Conditions

Shoulder Instability Subluxation Bilateral

Outcome Measures

Primary Outcomes (1)

• Number of patients with positive culture

  The primary endpoint, based on the culture result, is the number of patients with at least one positive culture

  Month 6

Secondary Outcomes (3)

• Walch-Duplay Questionnaire

  Month 6

• Constant score

  Month 6

• Bacteriological criterion

  Month 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with no history of previous shoulder surgery or suspicion of underlying infection, operated on in the first instance for anterior shoulder instability by the conventional Latarjet technique (open surgery).

You may qualify if:

• Patient 18 years of age or older, who has been informed of the research
• Patient who has undergone a first-line Latarjet operation
• Patient with three cultures performed on the coracoid bone blocks
• Patient regularly followed since the operation and for whom all data are available during the six-month follow-up visit.

You may not qualify if:

• Previous open shoulder surgery
• Associated rotator cuff injury requiring repair
• Clinical signs of preoperative infection
• Patient under court protection, guardianship or curatorship
• Patient who has indicated his or her opposition to the use of his or her medical data (by filling out and returning the non-opposition form that will be sent to him or her).

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Clinique du Sport

Paris, 75005, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 20, 2022
• Study Start: January 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)