Periprosthetic Hip InfectionPJI_H_MDNCT07299591
Analysis of Pharmacological Aspects Regarding Infection Free Survival After Surgical Treatment of a Periprosthetic Hip Infection: a Microdialysis Study
An observational study of Periprosthetic Hip Infection, run by University Hospital, Bonn at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periprosthetic Hip Infection
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 15 Nov 2025to 1 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- - known allergies to antibiotics gentamicin and vancomycin used within the spacer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Bonn
Bonn, North Rhine-Westphalia, 53127
Alexander Franz, +491703750718, alexander.franz@ukbonn.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Periprosthetic Hip Infection
- Keywords
- two-stage sxchange, infection, PJI, infection free survival, treatment monitoring, patient reported outcome measures, microdialysis, bone cement, spacer treatment
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients presenting with an infected hip prosthesis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Antibiotic concentrations measured in intraarticular samples generated by microdialysis will be compared to venous blood serum concentrations
Measured: Pre-Surgery (removal of the prothesis), during hospitalization of 14 days and before reimplantation of the prothesis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start15 Nov 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periprosthetic Hip InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Franz, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299591
- Sponsor's protocol ID
- 2025_C_PJI_Hip
- Acronym
- PJI_H_MD
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Immunological and Pharmacological Aspects Regarding Infection Free Survival After Surgical Treatment of a Periprosthetic Hip Infection During Hospitalization: a Microdialysis Study
- ClinicalTrials.gov ID
- NCT07299591
- Acronym / sponsor ID
- PJI_H_MD / 2025_C_PJI_Hip
- Conditions
- Periprosthetic Hip Infection
- Keywords
- two-stage sxchange, infection, PJI, infection free survival, treatment monitoring, patient reported outcome measures, microdialysis, bone cement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients presenting with an infected hip prosthesis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- - known allergies to antibiotics gentamicin and vancomycin used within the spacer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Periprosthetic Hip Infection
RecruitingObservational study
Analysis of the Etiopathogenesis of Postoperative Complications in Orthopedic Patients Using Knee and Hip Arthroplasty as an Example
Periprosthetic Joint Infection (PJI), Periprosthetic Knee Infection
Enrolling by invitationPhase 4
Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
Infections Joint Prosthetic, Overweight or Obesity
RecruitingObservational study
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
Revision Hip Arthroplasty, Aseptic Loosening of Prosthetic Joint
Recruiting
Evaluating XPERIENCE™ Advanced Surgical Irrigation
Hip Osteoarthritis, Hip Arthritis
Active, not recruiting
Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint Infection
Hip Prosthesis Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periprosthetic Hip Infection, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Franz, Dr. med., B. Sc. (+491703750718, alexander.franz@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.