Antibiotic Elution After Two-stage Knee Revision

NCT06944184 | Completed

• 1 other identifier: 2024_B
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periprosthetic Knee Infection

Keywords

two-stage exchange; infection; arthroplasty; PJI; microdialysis; minimal inhibitory concentration; bone cement; treatment monitoring

Outcome Measures

Primary Outcomes (1)

• antibiotic concentrations in intra-articular samples

  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.

  Concentrations are measured for 72 hours after spacer implantation.

Secondary Outcomes (1)

• Antibiotic concentrations in blood samples

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

Study Arms (1)

Patients presenting with an infected knee prosthesis

Device: Intraarticular microdialysis

Interventions

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.

Patients presenting with an infected knee prosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ten patients over 18 years with a periprosthetic knee infection after total knee arthorplasty and indication for prosthesis explanation and temporary spacer implantation.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Related Publications (3)

• Lazic I, Scheele C, Pohlig F, von Eisenhart-Rothe R, Suren C. Treatment options in PJI - is two-stage still gold standard? J Orthop. 2021 Jan 20;23:180-184. doi: 10.1016/j.jor.2020.12.021. eCollection 2021 Jan-Feb.

  PMID: 33551610 BACKGROUND

• Dhanani JA, Parker SL, Lipman J, Wallis SC, Cohen J, Fraser J, Barnett A, Chew M, Roberts JA. Recovery rates of combination antibiotic therapy using in vitro microdialysis simulating in vivo conditions. J Pharm Anal. 2018 Dec;8(6):407-412. doi: 10.1016/j.jpha.2018.07.003. Epub 2018 Jul 6.

  PMID: 30595948 BACKGROUND

• Moojen DJ, Hentenaar B, Charles Vogely H, Verbout AJ, Castelein RM, Dhert WJ. In vitro release of antibiotics from commercial PMMA beads and articulating hip spacers. J Arthroplasty. 2008 Dec;23(8):1152-6. doi: 10.1016/j.arth.2007.08.020. Epub 2008 Mar 4.

  PMID: 18534493 BACKGROUND

MeSH Terms

Conditions

Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med., B.Sc.

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 25, 2025
• Study Start: January 31, 2024
• Primary Completion: May 24, 2024
• Study Completion: July 20, 2024
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)