NCT06023238|Withdrawn
Study Stopped
withdrawn
Knee Prosthetic Joint Infection Antibiotic Elution
Antibiotic Elution Profile and Outcomes in the Treatment of Prosthetic Joint Infections of the Knee
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Sponsor study identifier
observational
0
1 country
1
Study Start
January 5, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 14, 2023
Actual (reported)September 5, 2023
Actual (reported)January 5, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Post-operative day 2 and during 2nd stage re-implantation evaluation (around 10 weeks according to standard of care)
Drain Output
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
up to 6 months following surgery
Re-operation Rates
30 days and 90 days post-operatively.
Re-admission Rates
30 days and 90 days post-operatively.
Pain Scores
Daily on postop day 0 until postop day 5, 3 weeks, 6 weeks and 10 weeks, 6 months postoperatively.
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.
Patients will all undergo standard of care treatment for a chronic total knee arthroplasty prosthetic joint infection.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
UPMC Shadyside
Pittsburgh, Pennsylvania, 15232, United States
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.
Slane 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.
Synovial fluid obtained in the post-operative setting as part of standard of care intra-articular post-operative drains or as part of standard of care intra-articular knee aspiration performed during re-implantation revaluation.
Johannes F Plate, MD, PhD
University of Pittsburgh Medical Center
0 participants (actual enrollment reported by the registry).
First Submitted
August 14, 2023
First Posted
September 5, 2023
Study Start
January 5, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Anagnostakos 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.
Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 5, 2026
Record last verified: 2026-02
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Source: ClinicalTrials.gov.
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