Clinical trial NCT06023238: Knee Prosthetic Joint Infection Antibiotic Elution
Official title: Antibiotic Elution Profile and Outcomes in the Treatment of Prosthetic Joint Infections of the Knee
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prosthetic-joint Infection
Arthroplasty Complications
Keywords: Prosthetic Joint Infection
Revision Total Knee Arthroplasty
Antibiotic Elution Profile
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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:

1. To evaluate the antibiotic elution profile and post-operative intra-synovial concentrations in the treatment of chronic PJI after TKA.
2. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Intra-articular Antibiotic Elution Profile
timeFrame: Post-operative day 2 and during 2nd stage re-implantation evaluation (around 10 weeks according to standard of care)
Secondary outcomes:
measure: Drain Output
timeFrame: Each 12 hours period until removal of the drain up to 5 days postoperatively based on drain output less than 30cc in 12 hours.
measure: Wound Healing Complications
timeFrame: up to 6 months following surgery
measure: Re-operation Rates
timeFrame: 30 days and 90 days post-operatively.
measure: Re-admission Rates
timeFrame: 30 days and 90 days post-operatively.
measure: Pain Scores
timeFrame: Daily on postop day 0 until postop day 5, 3 weeks, 6 weeks and 10 weeks, 6 months postoperatively.
measure: Second Stage Re-implantation Rates
timeFrame: Through study completion up to 1 year
measure: Knee aspiration cell count
timeFrame: 3 weeks, 6 weeks and 10 weeks - 6 months postoperatively.
measure: Knee aspiration culture
timeFrame: 3 weeks, 6 weeks and 10 weeks - 6 months postoperatively.
measure: C-reactive protein assessment
timeFrame: baseline, 10 weeks to 6 months posteroperatively
measure: ESR assessment
timeFrame: baseline, 10 weeks to 6 months posteroperatively
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Shadyside
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Johannes F Plate, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.