Culture Analysis Performed During a Latarjet Anterior Shoulder Stabilization Procedure.

NCT ID: NCT05658211

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Infection is a major cause of failure in shoulder arthroplasty and must be systematically sought at the time of revision, even if this is motivated by other complications (loosening, instability, periprosthetic fracture).

These cultures, performed in patients without clinical suspicion of infection, reveal, in 25 to 60% of cases, the presence of germs of cutaneous origin which, although generally considered to be non-virulent, continue to be debated as to their clinical significance and their implication in the failure of shoulder arthroplasty. Among these germs, propionibacterium acnes, staphylococcus epidermidis or coagulasenegative Staphylococcus are the most frequently identified.

The origin of these germs is still debated. Cultures of deep synovial fluid or tissues from patients receiving a first-line shoulder prosthesis show the presence of Cutibacterium acnes in 9% to 41% of cases despite preoperative antibiotic prophylaxis. These infections could be the consequence of contamination by a commensal germ during surgical exposure. Other authors consider them as an etiological factor in the development of shoulder arthritis. They would be more frequent in young subjects and male subjects.

The Latarjet procedure or coracoid bone block is commonly used in the surgical treatment of anterior shoulder instability.

It consists of cutting the coracoid bone with the coraco-biceps muscle that inserts on it, then passing it through the subscapularis muscle and fixing it on the scapula, thus creating a bone block. It can be performed by a conventional mini-invasive technique after an incision of 4 to 5 cm on the front of the shoulder or by arthroscopy.

The Latarjet procedure or coracoid bone block is commonly used in the surgical treatment of anterior shoulder instability.

It consists of cutting the coracoid bone with the coraco-biceps muscle that inserts on it, then passing it through the subscapularis muscle and fixing it on the scapula, thus creating a bone block. It can be performed by a conventional mini-invasive technique after an incision of 4 to 5 cm on the front of the shoulder or by arthroscopy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Shoulder Instability Subluxation Bilateral

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinique du Sport

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

COS-RGDS-2021-06-014

Identifier Type: -

Identifier Source: org_study_id