Knee Prosthetic Joint Infection Antibiotic Elution

Arthroplasty Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06023238
• Other study ID #: STUDY22070087
• Status: Recruiting
• Start date: June 5, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2023
• Source: University of Pittsburgh
• Contact: Johannes F Plate, MD, PhD
• Phone: 412-802-4100
• Email: platefj2[@]upmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis, Infectious
• Arthroplasty Complications
• Communicable Diseases
• Infections

Intervention

Procedure:
• Treatment of Chronic TKA PJI
Patients will all undergo standard of care treatment for a chronic total knee arthroplasty prosthetic joint infection.

Locations

Country	Name	City	State
United States	UPMC Shadyside	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

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