Knee Prosthetic Joint Infection Antibiotic Elution

NCT ID: NCT06023238

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-05
• Study Completion Date: 2029-12-31

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.

Conditions

Prosthetic-joint Infection; Arthroplasty Complications

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Treatment of Chronic TKA PJI

Intervention Type: PROCEDURE

Patients will all undergo standard of care treatment for a chronic total knee arthroplasty prosthetic joint infection.

Interventions

Treatment of Chronic TKA PJI

Patients will all undergo standard of care treatment for a chronic total knee arthroplasty prosthetic joint infection.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

F. Johannes Plate

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Johannes F Plate, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center

Locations

UPMC Shadyside

Pittsburgh, Pennsylvania, United States

Countries

United States

Central Contacts

Johannes F Plate, MD, PhD

Role: CONTACT

platefj2@upmc.edu

412-802-4100

Matthew F Gong, MD

Role: CONTACT

gongm2@upmc.edu

412-605-3262

Facility Contacts

Johannes F Plate, MD, PhD

Role: primary

platefj2@upmc.edu

412-802-4100

Matthew F Gong, MD

Role: backup

gongm2@upmc.edu

412-605-3262

References

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.

Reference Type: BACKGROUND

PMID: 25272207 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28876459 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19404802 (View on PubMed)

Other Identifiers

STUDY22070087

Identifier Type: -

Identifier Source: org_study_id