Clinical trial NCT05658211: Culture Analysis Performed During a Latarjet Anterior Shoulder Stabilization Procedure.
Official title: Culture Analysis Performed During a Latarjet Anterior Shoulder Stabilization Procedure.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Instability Subluxation Bilateral
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of patients with positive culture
timeFrame: Month 6
Secondary outcomes:
measure: Walch-Duplay Questionnaire
timeFrame: Month 6
measure: Constant score
timeFrame: Month 6
measure: Bacteriological criterion
timeFrame: Month 6
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique du Sport
Study officials:
References: