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

December 9, 2025 updated by: Alexander Franz, University Hospital, Bonn

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Periprosthetic joint infection (PJI) of the hip is a severe complication following joint arthroplasty, with rising incidence and reinfection rates as high as 30-35 % despite the widely used two-stage revision approach (DOI: 10.36186/reporteprd112025). This treatment combines systemic antibiotic treatment and local therapy via antibiotic impregnated bone cement - so called spacers. During a first surgery the infected prosthesis is removed and a temporary spacer is implemented. It is either preformed for hip joints or intra operatively formed for knee joints and used to temporarily fill the joint cavity and stabilize the joint. Both spacer designs include the same antibiotics gentamicin and vancomycin. After six to eight weeks, during which systemic antibiotics (e.g. cefuroxime, cefazolin) are applied for two weeks and continued orally, the spacer is removed in a second surgery and a new prosthesis is implemented into a pathogen free compartment. With this treatment patients often experience prolonged immobility, delayed rehabilitation, and reduced quality of life, along with causing significant healthcare costs (DOI: 10.1016/j.jiph.2020.09.006, 10.3389/fmed.2021.552669,10.1016/j.joca.2017.07.022). Despite clinical relevance, there is a lack of in vivo data on sustained and therapeutic local antibiotic elution during spacer implantation and their correlation with clinical outcomes. A previous pilot study by the same research group used the technique of microdialysis for 72 hours postoperatively, only on patients with PJI of the knee (DOI: 10.3390/antibiotics14080742). It showed microdialysis as a feasible method and displayed fast declining, yet therapeutic concentrations eluted from the spacer for 72 hours. Microdialysis is a technique to continuously generate samples from interstitial fluid of human tissue based on the principle of passive diffusion along a semipermeable membrane (DOI: 10.1016/j.xphs.2016.08.016). This study now aims to extend the surveillance period to 14 days postoperatively and investigate the intraarticular compartment of hip joints during PJI treatment with two-stage revision. Microdialysis will be used again to measure locally eluted antibiotic concentrations as well as inflammatory markers. Furthermore, during the second surgery intraarticular samples will be taken intraoperatively to look at antibiotic concentrations six weeks at spacer removal. Found antibiotic concentrations will be correlated to reinfection rates at 12 months following two-stage revision. Furthermore, the quality of life and functional recovery in regard to infection-free survival and local antibiotic levels will be investigated. For this, functional testing (e.g., 6-Minute-Walking-Test, Timed-Up-And-Go) as well as patient reported outcome measures (e.g. SF-36,Hip Injury and Osteoarthritis Outcome Score) will be used and information will be gathered before and at multiple follow-up time points until 12 months after surgery. By using two different spacer designs (e.g., surgeon made vs. manufacture-made) elution kinetics and concentration levels will be examined based on process of preparation. The correlation of antibiotic findings with clinical and patient-reported outcomes seeks to fill a critical knowledge gap regarding the pharmacological efficacy of spacers in two-stage revision.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Germany, 53127

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • - known allergies to antibiotics gentamicin and vancomycin used within the spacer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients presenting with an infected hip prosthesis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intraarticular concentrations of local antibiotics
Time Frame: Pre-Surgery (prothesis removal), during 14 days of hospitalization as well as pre-surgery of the reimplantation (approx. six weeks after the first surgery)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison intraarticular antibiotic concentrations to venous blood concentrations
Time Frame: Pre-Surgery (removal of the prothesis), during hospitalization of 14 days and before reimplantation of the prothesis.
Antibiotic concentrations measured in intraarticular samples generated by microdialysis will be compared to venous blood serum concentrations
Pre-Surgery (removal of the prothesis), during hospitalization of 14 days and before reimplantation of the prothesis.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation between infection free survival and antibiotic concentrations
Time Frame: Preoperatively, during hospitalisation, preoperatively before the second surgery and at follow up time points (6 weeks, 3 months, 6 months, 12 months).
Analyzed concentrations of local and systemic antibiotic concentrations will be correlated with infection free survival within the follow up (infection free survival: successfull wound healing, no signs of lossening within X-rays, no increase of inflammatory markers).
Preoperatively, during hospitalisation, preoperatively before the second surgery and at follow up time points (6 weeks, 3 months, 6 months, 12 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bonn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025_C_PJI_Hip

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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