Knee Prosthetic Joint Infection Antibiotic Elution

NCT06023238 | Withdrawn

• 1 other identifier: STUDY22070087
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty Complications; Prosthetic-joint Infection

Keywords

Prosthetic Joint Infection; Revision Total Knee Arthroplasty; Antibiotic Elution Profile

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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.

• Wound Healing Complications

  up to 6 months following surgery

• Re-operation Rates

  30 days and 90 days post-operatively.

• Re-admission Rates

  30 days and 90 days post-operatively.

• Pain Scores

  Daily on postop day 0 until postop day 5, 3 weeks, 6 weeks and 10 weeks, 6 months postoperatively.

Study Arms (1)

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.

Procedure: Treatment of Chronic TKA PJI

Interventions

Treatment of Chronic TKA PJI PROCEDURE

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

Chronic TKA PJI Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Shadyside

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (3)

• 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.

  PMID: 25272207 BACKGROUND

• 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.

  PMID: 28876459 BACKGROUND

• 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.

  PMID: 19404802 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Synovial fluid obtained in the post-operative setting as part of standard of care intra-articular post-operative drains or as part of standard of care intra-articular knee aspiration performed during re-implantation revaluation.

Study Officials

• Johannes F Plate, MD, PhD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: September 5, 2023
• Study Start: January 5, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)