Prosthetic-joint InfectionNCT06023238
Knee Prosthetic Joint Infection Antibiotic Elution
An observational study of Prosthetic-joint Infection and Arthroplasty Complications, run by University of Pittsburgh at 1 site in United States.
Trial summary
Patients presenting with prosthetic joint infections of a total knee replacement who are treated with an antibiotic spacer will be observed prospectively for their response to treatment and antibiotic elution profiles will be measured post-operatively utilizing mass spectrometry from synovial fluid acquired as part of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prosthetic-joint Infection, Arthroplasty Complications
- What is being tested?
- Treatment of Chronic TKA PJI
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2026to 31 Dec 2029
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will comprise of patients who have had a previous total knee arthroplasty (TKA), presenting with clinical and laboratory findings concerning for a chronic TKA prosthetic joint infection (PJI) undergoing staged surgical management consisting of resection arthroplasty followed by mobile antibiotic spacer placement. Patients who have had prior surgical treatment of a PJI and are less than 18 years of age will not be included in the study population.
Who may be able to join
- Patients planned for treatment of a total knee arthroplasty prosthetic joint infection
- Patients greater than 18 years of age
- Patients able to provide informed consent
Who cannot join
- Prior history of ipsilateral or contralateral prosthetic joint infection warranting operative management
- Patients less than 18 years of age
- Patients unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antibiotic Elution Profile and Outcomes in the Treatment of Prosthetic Joint Infections of the Knee
Patients presenting with prosthetic joint infections of a total knee replacement who are treated with an antibiotic spacer will be observed prospectively for their response to treatment and antibiotic elution profiles will be measured post-operatively utilizing mass spectrometry from synovial fluid acquired as part of standard of care in the management of prosthetic joint infection. Secondary outcomes including post-operative complications, re-operation rates, and re-admission rates will also be compared.
Read the detailed description
The current study aims to assess the surgical and patient-reported outcomes and in vivo antibiotic elution profile of the management of total knee arthroplasty (TKA) prosthetic joint infection (PJI). Within the standard of care, TKA PJI is treated via a resection arthroplasty and antibiotic cement spacer placement. Patients will be enrolled if they are undergoing surgical management for a chronic TKA PJI and will receive surgical treatment according to the standard of care. In the post-operative period, patients will be monitored for surgical and patient-reported outcomes including re-operation rate, pain scores, complication rates, and re-infection rates. Synovial fluid obtained from intra-articular postoperative drains and at postoperative knee aspirations during reimplantation evaluations will also be utilized for antibiotic concentration quantification via mass spectrometry, if sufficient specimen is available. Patient who undergo surgical management for their chronic TKA PJI will then have their measured antibiotic elution concentrations compared. The study hypothesizes that patients undergoing treatment of a PJI with antibiotic spacer + antibiotic cement spacer will have better surgical and patient-related outcomes with higher antibiotic elution concentrations. These improved outcomes would include lower re-operation rates, lower pain scores, lower wound healing complications, and higher rates of second stage re-implantation observed in patients with higher antibiotic elution concentrations.
Specific aims:
- To evaluate the antibiotic elution profile and post-operative intra-synovial concentrations in the treatment of chronic PJI after TKA.
- To evaluate surgical and patient-related outcomes in chronic TKA PJI patients following implant resection and knee spacer placement, including amount of post-operative drain output, wound healing complications, 30- and 90-day risk of re-operation, pain scores, and rate of second stage re-implantation.
- Being tested
- Treatment of Chronic TKA PJI
- Keywords
- Prosthetic Joint Infection, Revision Total Knee Arthroplasty, Antibiotic Elution Profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of Chronic TKA PJIProcedure or surgery
Patients will all undergo standard of care treatment for a chronic total knee arthroplasty prosthetic joint infection.
| Study group | Role | What they receive |
|---|---|---|
| Chronic TKA PJI Group | Patients presenting for surgical management of a chronic total knee arthroplasty (TKA) prosthetic joint infection (PJI). Patients will be excluded if they are less than 18 years of age, have a prior history of ipsilateral or contralateral PJI warranting operative management, or are unable to provide informed consent. Receives: Procedure: Treatment of Chronic TKA PJI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-articular Antibiotic Elution Profile
Antibiotic concentration will be quantified utilizing mass spectrometry from intra-articular synovial fluid obtained from post-operative drain and knee aspirations performed for re-implantation evaluation.
Measured: Post-operative day 2 and during 2nd stage re-implantation evaluation (around 10 weeks according to standard of care)
Secondary outcomes (10)
Drain Output
Measured volume of output from post-operative drain will be quantified every 12 hours
Measured: Each 12 hours period until removal of the drain up to 5 days postoperatively based on drain output less than 30cc in 12 hours.
Wound Healing Complications
Any issues with wound healing including closure, occurrence of infection, high drainage, or hematoma formation will be among wound healing complications which are measured.
Measured: up to 6 months following surgery
Re-operation Rates
Rates of return to operating room will be quantified over course of 30 days and 90 days.
Measured: 30 days and 90 days post-operatively.
Re-admission Rates
Rates of re-admission will be quantified over course of 30 days and 90 days.
Measured: 30 days and 90 days post-operatively.
Pain Scores
Pain scores utilizing visual analog scale from 0 to 10 will be quantified during post-operative course.
Measured: Daily on postop day 0 until postop day 5, 3 weeks, 6 weeks and 10 weeks, 6 months postoperatively.
Second Stage Re-implantation Rates
Rates of successful second stage re-implantation will be quantified during the post-operative course.
Measured: Through study completion up to 1 year
Knee aspiration cell count
Knee aspiration with number of white cells less than 1300
Measured: 3 weeks, 6 weeks and 10 weeks - 6 months postoperatively.
Knee aspiration culture
Knee aspiration without evidence of bacteria on bacterial culture
Measured: 3 weeks, 6 weeks and 10 weeks - 6 months postoperatively.
C-reactive protein assessment
C-reactive protein normalization (less than 1mg/dl)
Measured: baseline, 10 weeks to 6 months posteroperatively
ESR assessment
Erythrocyte sedimentation rate normalization (less than 20 mm/hr)
Measured: baseline, 10 weeks to 6 months posteroperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start5 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Why it stopped: withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prosthetic-joint InfectionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, F. Johannes Plate, University of Pittsburgh
- Investigators
- Johannes F Plate, MD, PhD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023238
- Sponsor's protocol ID
- STUDY22070087
- Status last verified
- Feb 2026
- First submitted
- 14 Aug 2023
- Last updated
- 5 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There are no plans at present to make individual participant data (IPD) available to other researchers, however we may share de-identified data with other researchers in the future.
Publications
Chen AF, Parvizi J. Antibiotic-loaded bone cement and periprosthetic joint infection. J Long Term Eff Med Implants. 2014;24(2-3):89-97. doi: 10.1615/jlongtermeffmedimplants.2013010238.
PubMed 25272207Slane J, Gietman B, Squire M. Antibiotic elution from acrylic bone cement loaded with high doses of tobramycin and vancomycin. J Orthop Res. 2018 Apr;36(4):1078-1085. doi: 10.1002/jor.23722. Epub 2017 Sep 20.
PubMed 28876459Anagnostakos K, Wilmes P, Schmitt E, Kelm J. Elution of gentamicin and vancomycin from polymethylmethacrylate beads and hip spacers in vivo. Acta Orthop. 2009 Apr;80(2):193-7. doi: 10.3109/17453670902884700.
PubMed 19404802
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Elution Profile and Outcomes in the Treatment of Prosthetic Joint Infections of the Knee
- ClinicalTrials.gov ID
- NCT06023238
- Acronym / sponsor ID
- STUDY22070087
- Keywords
- Prosthetic Joint Infection, Revision Total Knee Arthroplasty, Antibiotic Elution Profile
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 5 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 5 Sep 2023 (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.
Patients presenting with prosthetic joint infections of a total knee replacement who are treated with an antibiotic spacer will be observed prospectively for their response to treatment and antibiotic elution profiles will be measured post-operatively utilizing mass spectrometry from synovial fluid acquired as part of standard of care in the management of prosthetic joint infection. Secondary outcomes including post-operative complications, re-operation rates, and re-admission rates will also be compared.
Detailed description
The current study aims to assess the surgical and patient-reported outcomes and in vivo antibiotic elution profile of the management of total knee arthroplasty (TKA) prosthetic joint infection (PJI). Within the standard of care, TKA PJI is treated via a resection arthroplasty and antibiotic cement spacer placement. Patients will be enrolled if they are undergoing surgical management for a chronic TKA PJI and will receive surgical treatment according to the standard of care. In the post-operative period, patients will be monitored for surgical and patient-reported outcomes including re-operation rate, pain scores, complication rates, and re-infection rates. Synovial fluid obtained from intra-articular postoperative drains and at postoperative knee aspirations during reimplantation evaluations will also be utilized for antibiotic concentration quantification via mass spectrometry, if sufficient specimen is available. Patient who undergo surgical management for their chronic TKA PJI will then have their measured antibiotic elution concentrations compared. The study hypothesizes that patients undergoing treatment of a PJI with antibiotic spacer + antibiotic cement spacer will have better surgical and patient-related outcomes with higher antibiotic elution concentrations. These improved outcomes would include lower re-operation rates, lower pain scores, lower wound healing complications, and higher rates of second stage re-implantation observed in patients with higher antibiotic elution concentrations.
Specific aims:
- To evaluate the antibiotic elution profile and post-operative intra-synovial concentrations in the treatment of chronic PJI after TKA.
- To evaluate surgical and patient-related outcomes in chronic TKA PJI patients following implant resection and knee spacer placement, including amount of post-operative drain output, wound healing complications, 30- and 90-day risk of re-operation, pain scores, and rate of second stage re-implantation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic TKA PJI Group | – | Procedure: Treatment of Chronic TKA PJIPatients presenting for surgical management of a chronic total knee arthroplasty (TKA) prosthetic joint infection (PJI). Patients will be excluded if they are less than 18 years of age, have a prior history of ipsilateral or contralateral PJI warranting operative management, or are unable to provide informed consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will comprise of patients who have had a previous total knee arthroplasty (TKA), presenting with clinical and laboratory findings concerning for a chronic TKA prosthetic joint infection (PJI) undergoing staged surgical management consisting of resection arthroplasty followed by mobile antibiotic spacer placement. Patients who have had prior surgical treatment of a PJI and are less than 18 years of age will not be included in the study population.
Key inclusion criteria (3 listed)
- Patients planned for treatment of a total knee arthroplasty prosthetic joint infection
- Patients greater than 18 years of age
- Patients able to provide informed consent
Key exclusion criteria (3 listed)
- Prior history of ipsilateral or contralateral prosthetic joint infection warranting operative management
- Patients less than 18 years of age
- Patients unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment of Chronic TKA PJIPatients will all undergo standard of care treatment for a chronic total knee arthroplasty prosthetic joint infection. | Procedure or surgery | Chronic TKA PJI Group |
Primary outcome
Intra-articular Antibiotic Elution Profile
Time frame: Post-operative day 2 and during 2nd stage re-implantation evaluation (around 10 weeks according to standard of care)
Antibiotic concentration will be quantified utilizing mass spectrometry from intra-articular synovial fluid obtained from post-operative drain and knee aspirations performed for re-implantation evaluation.
10 secondary outcomes
Drain Output
Time frame: Each 12 hours period until removal of the drain up to 5 days postoperatively based on drain output less than 30cc in 12 hours.
Wound Healing Complications
Time frame: up to 6 months following surgery
Re-operation Rates
Time frame: 30 days and 90 days post-operatively.
Re-admission Rates
Time frame: 30 days and 90 days post-operatively.
Pain Scores
Time frame: Daily on postop day 0 until postop day 5, 3 weeks, 6 weeks and 10 weeks, 6 months postoperatively.
Second Stage Re-implantation Rates
Time frame: Through study completion up to 1 year
Knee aspiration cell count
Time frame: 3 weeks, 6 weeks and 10 weeks - 6 months postoperatively.
Knee aspiration culture
Time frame: 3 weeks, 6 weeks and 10 weeks - 6 months postoperatively.
C-reactive protein assessment
Time frame: baseline, 10 weeks to 6 months posteroperatively
ESR assessment
Time frame: baseline, 10 weeks to 6 months posteroperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Background: PubMed 25272207Chen AF, Parvizi J. Antibiotic-loaded bone cement and periprosthetic joint infection. J Long Term Eff Med Implants. 2014;24(2-3):89-97. doi: 10.1615/jlongtermeffmedimplants.2013010238.
- Background: PubMed 28876459Slane J, Gietman B, Squire M. Antibiotic elution from acrylic bone cement loaded with high doses of tobramycin and vancomycin. J Orthop Res. 2018 Apr;36(4):1078-1085. doi: 10.1002/jor.23722. Epub 2017 Sep 20.
- Background: PubMed 19404802Anagnostakos K, Wilmes P, Schmitt E, Kelm J. Elution of gentamicin and vancomycin from polymethylmethacrylate beads and hip spacers in vivo. Acta Orthop. 2009 Apr;80(2):193-7. doi: 10.3109/17453670902884700.
- Individual participant dataSharing planned: Undecided. There are no plans at present to make individual participant data (IPD) available to other researchers, however we may share de-identified data with other researchers in the future.
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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. This study is not recruiting at the moment.
Johannes F Plate, MD, PhD principal investigator
University of Pittsburgh Medical Center
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 Prosthetic-joint Infection and Arthroplasty Complications, run by University of Pittsburgh at 1 site in United States.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 5 Feb 2026. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-articular Antibiotic Elution Profile (time frame: Post-operative day 2 and during 2nd stage re-implantation evaluation (around 10 weeks according to standard of care)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06023238, which also lists 3 linked publications.
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 5 Feb 2026.