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

Hip or Knee Replacement Clinical Trial

— HKP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06183606
• Other study ID #: 7411
• Status: Recruiting
• Start date: June 14, 2019
• Est. completion date: December 2023

Study information

• Verified date: December 2023
• Source: University Hospital, Strasbourg, France
• Contact: Jeannot GAUDIAS, MD
• Phone: 33 3 68 76 50 62
• Email: jeannot.gaudias[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip or Knee Replacement

Locations

Country	Name	City	State
France	Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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