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Interest of High-dose Gentamicin Cement Associated With Clindamycin in Changes of Hip and Knee Prostheses

NCT ID: NCT06183606

Last Updated: 2023-12-27

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

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-14

Study Completion Date

2023-12-31

Brief Summary

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A hip or knee prosthesis can be cemented or not. The team of orthopedic surgeons from the CCOM (Centre de Chirurgie Orthopédique et de la Main) has been cementing all hip and knee prosthesis poses for many years using gentamycin cement as recommended by the French Society of Orthopedic Surgery. and trauma (SOFCOT) (1). Data obtained from the Norwegian Register of Hip Prostheses show that the best survival curve for these prostheses is found for prostheses cemented with gentamycin cement (all causes combined). Independently of the risk of aseptic loosening, infection on the prosthesis is the second complication of arthroplasty. The defense mechanism against pathogens in contact with an implant is the formation of a biofilm. Biofilm bacteria are metabolically inactive and characterized by stationary growth. Due to their slower replication, bacteria in biofilm are up to 1000 times more resistant to antibiotics. Therefore, the optimization of local antibiotic prophylaxis is essential.

Detailed Description

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Conditions

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Hip or Knee Replacement

Keywords

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Hip Replacement knee Replacement Local antibiotic prophylaxis Antibiotic cement Gentamicin cement Clindamycin

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Adult subject (≥18 years old)
* Patient operated on at the HUS between 01/02/2017 and 31/01/2019, for replacement of hip and knee prostheses
* Patient having given their consent for the reuse of their data for the purposes of this research

Exclusion Criteria

\- Patient who expressed their opposition to participating in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jeannot GAUDIAS, MD

Role: CONTACT

Phone: 33 3 68 76 50 62

Email: [email protected]

Facility Contacts

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Jeannot GAUDIAS, MD

Role: primary

Other Identifiers

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7411

Identifier Type: -

Identifier Source: org_study_id