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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hip or Knee Replacement

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Jeannot GAUDIAS, MD; Phone Number: 33 3 68 76 50 62; Email: jeannot.gaudias@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France
    • Principal Investigator: Jeannot GAUDIAS, MD
    • Sub-Investigator: Julien GODET, Statistician
    • Contact: Jeannot GAUDIAS, MD; Phone Number: 33 3 68 76 50 62; Email: jeannot.gaudias@chru-strasbourg.fr
    • Sub-Investigator: Marie Hamon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult subject (≥18 years old) operated on at the HUS between 01/02/2017 and 31/01/2019, for replacement of hip and knee prostheses.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retrospective study of surgical site infections (SSI) after changes of hip and knee prostheses	Retrospective description of the benefit of high-dose gentamicin cement combined with clindamycin in hip and knee prosthesis changes	Through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2019
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Estimated): December 27, 2023

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Hip Replacement; Clindamycin; knee Replacement; Local antibiotic prophylaxis; Antibiotic cement; Gentamicin cement
• Other Study ID Numbers: 7411

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No