PCA Administration in Prosthetic Joint Infection

August 18, 2025 updated by: Dr. Dean Reeves, Dr. Dean Reeves Clinic

Effects of Dietary Protocatechuic Acid (PCA) on the Function and Structure of Participants With Knee Prosthetic Joint Infection (PJI) as Measured by Standard Biomarkers

Determine if dietary protocatechuic acid (PCA) will affect health biomarkers in patient undergoing revision surgery for a knee prosthetic joint infection

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients who are scheduled to undergo revision surgery for a knee prosthetic joint infection are given PCA prior to surgery for a time period determined by a previous pilot study. PCA is then post-operatively until anticoagulation is stopped, and then will be resumed for four years post revision surgery. Measurement of changes in glucose control, immunity, will be measured over the first 3 months post-revision, and the post-revision reinfection rate over the full 4 years will be compared to a cohort rate

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 3 weeks or more after total knee arthroplasty
  • One or more symptoms of infection, including redness, swelling, pain, increasing range of motion loss, fever, nausea, and loss of appetite.
  • WBC count of aspirate >50,000 cells per μL

Exclusion Criteria:

  • Not willing to undergo blood draw at 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PCA administraton
Dietary supplement: Oral PCA
PCA 1,000 mg BID until surgery, held until anticoagulation, and resumed at 1,000 mg daily for 4 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in immunity factor CXCL9 from 0 to 3 months
Time Frame: 0 and 3 months
0 and 3 months
Change in HbA1c from 0 to 3 months
Time Frame: 0 and 3 months
0 and 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Reinfection rate after revision for prosthetic joint infection
Time Frame: 0 to 4 years
0 to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Dean Reeves Clinic

Collaborators

Lanny Johnson, M.D.
Leo Whiteside, M.D.

Investigators

  • Principal Investigator: Kenneth D Reeves, M.D., K. Dean Reeves, M.D., P.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

September 7, 2024

First Submitted That Met QC Criteria

September 10, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 20, 2025

Last Update Submitted That Met QC Criteria

August 18, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCAinPJI-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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