NCT06023238

Knee Prosthetic Joint Infection Antibiotic Elution

Antibiotic Elution Profile and Outcomes in the Treatment of Prosthetic Joint Infections of the Knee

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
PROCEDURE	Treatment of Chronic TKA PJI	Patients will all undergo standard of care treatment for a chronic total knee arthroplasty prosthetic joint infection.

Timeline

• Start date: 2026-01-05
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2023-09-05
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States