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OpenTrials
Completed

NCT Number: NCT05658211

Culture Analysis Performed During a Latarjet Anterior Shoulder Stabilization Procedure.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique du Sport

Paris, 75005, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Number of patients with positive culture

    Time frame: Month 6

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

Secondary outcomes

  1. Walch-Duplay Questionnaire

    Time frame: Month 6

    The Walch questionnaire includes a descriptive part (type and level of sport practiced, dominant score) and an evaluation scale of subjective and objective data (stability, pain, recovery of sport level, mobility) to assess the clinical result of the shoulder stabilization. The score ranges from 0 to 100. The result is considered excellent for a score of 91 to 100 points, good for 76 to 90 points, average for 51 to 75 points, and poor for a score of 50 points or less.

  2. Constant score

    Time frame: Month 6

    The Constant and Murley score explores several domains: pain, activity, strength and mobility.

    The total score varies from 0 to 100 points, 100 points corresponding to a normal shoulder and 0 to a totally deficient shoulder.

  3. Bacteriological criterion

    Time frame: Month 6

    Nature of germs identified in culture

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: CISAL

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 20, 2022
Registry last updated
Dec 20, 2022

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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