Knee Prosthetic Joint Infection Antibiotic Elution

Not yet recruiting

• Conditions: Arthroplasty Complications; Prosthetic-joint Infection

• Registration Number: NCT06023238
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-08-31
• Study First Posted: 2023-09-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-12
• Last Update Posted: 2025-04-16
• Study Start: 2025-09-05
• Primary Completion: 2027-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intra-articular Antibiotic Elution Profile	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.

Secondary Outcome Measures

Name	Time	Method
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.	Measured volume of output from post-operative drain will be quantified every 12 hours
Wound Healing Complications	up to 6 months following surgery	Any issues with wound healing including closure, occurrence of infection, high drainage, or hematoma formation will be among wound healing complications which are measured.
Re-admission Rates	30 days and 90 days post-operatively.	Rates of re-admission will be quantified over course of 30 days and 90 days.
Re-operation Rates	30 days and 90 days post-operatively.	Rates of return to operating room will be quantified over course of 30 days and 90 days.
ESR assessment	baseline, 10 weeks to 6 months posteroperatively	Erythrocyte sedimentation rate normalization (less than 20 mm/hr)
Second Stage Re-implantation Rates	Through study completion up to 1 year	Rates of successful second stage re-implantation will be quantified during the post-operative course.
C-reactive protein assessment	baseline, 10 weeks to 6 months posteroperatively	C-reactive protein normalization (less than 1mg/dl)
Pain Scores	Daily on postop day 0 until postop day 5, 3 weeks, 6 weeks and 10 weeks, 6 months postoperatively.	Pain scores utilizing visual analog scale from 0 to 10 will be quantified during post-operative course.
Knee aspiration cell count	3 weeks, 6 weeks and 10 weeks - 6 months postoperatively.	Knee aspiration with number of white cells less than 1300
Knee aspiration culture	3 weeks, 6 weeks and 10 weeks - 6 months postoperatively.	Knee aspiration without evidence of bacteria on bacterial culture

Trial Locations

Locations (1)

UPMC Shadyside; 🇺🇸 Pittsburgh, Pennsylvania, United States