Analysis of Pharmacological Aspects Regarding Infection Free Survival After Surgical Treatment of a Periprosthetic Hip Infection: a Microdialysis Study

NCT07299591 | Recruiting

• 1 other identifier: 2025_C_PJI_Hip
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to use the technique of microdialysis to analyse the intraarticular space of the hip joint after removal of a periprosthetic joint infection affected endoprosthesis and implantation of an antibiotic-containing cement spacer over the entire period of the first hospitalization (usually 14 days) to closely monitor pharmacological and immunological aspects. In detail, antibiotic concentrations in the joint cavity and systemic circulation will be assessed according to reinfection rates, infection-free survival and fucntional outcome over a 12-month folluw-up period.

Conditions

Periprosthetic Hip Infection

Keywords

two-stage sxchange; infection; PJI; infection free survival; treatment monitoring; patient reported outcome measures; microdialysis; bone cement; spacer treatment

Outcome Measures

Primary Outcomes (1)

• Intraarticular concentrations of local antibiotics

  Microdialysis will help to generate intraarticular hip joint samples after removal of an infectes prosthesis and spacer implantation. These samples will be analysed for spacer eluted antibiotics.

  Pre-Surgery (prothesis removal), during 14 days of hospitalization as well as pre-surgery of the reimplantation (approx. six weeks after the first surgery)

Secondary Outcomes (1)

• Comparison intraarticular antibiotic concentrations to venous blood concentrations

  Pre-Surgery (removal of the prothesis), during hospitalization of 14 days and before reimplantation of the prothesis.

Other Outcomes (1)

• Correlation between infection free survival and antibiotic concentrations

  Preoperatively, during hospitalisation, preoperatively before the second surgery and at follow up time points (6 weeks, 3 months, 6 months, 12 months).

Study Arms (1)

Patients presenting with an infected hip 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

30 patients over 18 years of age presenting with PJI after total hip arthroplasty and indication for prosthesis explantation and temporary spacer implantation

You may qualify if:

• clinical indication for two-stage revision of hip PJI
• approval for surgery by the orthopedic and anesthesiologic department
• 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 antibiotics gentamicin and vancomycin used within the spacer

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

MeSH Terms

Conditions

Infections

Central Study Contacts

Alexander Franz, Dr. med., B. Sc.

CONTACT

+491703750718; alexander.franz@ukbonn.de

Julika Behrens

CONTACT

+4915752849422; julika.behrens@ukbonn.de

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: August 25, 2025
• First Posted: December 23, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)