Skip to main content
OpenTrials
Completed

NCT Number: NCT06944184

Antibiotic Elution After Two-stage Knee Revision

The goal of this observational study is to monitor the eluted antibiotic concentrations of gentamicin and vancomycin by a static knee cement spacer in patients being treated for periprosthetic infections of the knee. The main question aims to answer if eluted antibiotics are in a therapeutic range for treatment at sight of infection. Secondarily, local antibiotic concentrations are compared with systemic blood levels, as are systemically applied antibiotics compared to intra-articular concentrations. Intra-articular samples are collected over a 72 hour postoperative period.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Periprosthetic Knee Infection Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

About this study

The present study moinitors antibiotic concentrations eluted by a static cement knee spacer as two-stage revision treatment of a knee PJI. The static cement spacer consists of COPAL G+V cement containing 2g of vancomycin and 0.5g of gentamicin. Microdialysis is used as a technique for continuous extra cellular sample collection directly from the knee joint cavity. It is implemented guided by a drainage tube during the surgery to remove the infected prosthesis and implement the spacer. Over a 72 hour period samples directly from the knee joint are generated continiously. These are analyzed for the eluded antibiotic concentrations of gentamicin and vancomycin from the knee spacer. Once every 24 hours venous blood samples were collected as well and analyzed for gentamicin and vancomycin and also systemically applied antibiotics (a.e. cefuroxim, clindamycin).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • clinical indication for a two-staged revision of a knee PJI
  • approval for surgery by the orthopedic and anesthesiologic departments
  • being over 18 years of age
  • written, informed consent after detailed patient information about the study protocol and possible study-dependent risks

Exclusion criteria

  • known allergies to the antibiotics gentamicin and vancomycin contained in the spacer

Treatment and study plan

Intraarticular microdialysis

Device

The intervention decive is placed during the routine surgery to remove the infected knee prosthesis and implantation of the static cement spacer. A microdialysis catheter is implemented to generate continious intra-articular samples of the knee joint. To ensure complete removal and no damage of the membrane it is inserted via a regular drainage tube. The catheter membrane is placed intra-articularly next to the spacer and continious to an outlet tube for sample collection.

Primary outcomes

  1. antibiotic concentrations in intra-articular samples

    Time frame: Concentrations are measured for 72 hours after spacer implantation.

    Both locally through the spacer eluted antibiotics (gentamicin and vancomycin) and systemically administered antibiotics (e.g. cefuroxim, clindamycin) are measured in intra-articular knee samples.

Secondary outcomes

  1. Antibiotic concentrations in blood samples

    Time frame: Antibiotic concentrations are measured once every 24 hours after spacer implantation. In total at three time points during the 72 hour observation period.

    Antibiotic concentrations eluted by the spacer (gentamicin, vancomycin) and systemically administered antibiotics (e.g. cefuroxim, clindamycin) are measured in venous blood samples.

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Official study title

In Vivo Antibiotic Elution During Two-Stage Knee Revision: A Microdialysis Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 25, 2025
Registry last updated
Apr 25, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.