Antibiotic Elution After Two-stage Knee Revision

NCT ID: NCT06944184

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2024-07-20

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.

Detailed Description

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).

Conditions

Periprosthetic Knee Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients presenting with an infected knee prosthesis

Intraarticular microdialysis

Intervention Type: 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.

Interventions

Intraarticular microdialysis

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bonn

OTHER

Sponsor Role: lead

Responsible Party

Alexander Franz

Dr. med., B.Sc.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Bonn

Bonn, North Rhine-Westphalia, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 33551610 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30595948 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18534493 (View on PubMed)

Other Identifiers

2024_B

Identifier Type: -

Identifier Source: org_study_id