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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06183606

Acronym

HKP

Enrollment

300

Registered

2023-12-27

Start date

2019-06-14

Completion date

2023-12-31

Last updated

2023-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip or Knee Replacement

Keywords

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

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

France

Contacts

Primary ContactJeannot GAUDIAS, MD

jeannot.gaudias@chru-strasbourg.fr33 3 68 76 50 62

Outcome results