PCA Loading Time Before Knee Prosthetic Joint Infection Revision

February 4, 2025 updated by: Dr. Dean Reeves, Dr. Dean Reeves Clinic

The Effects Of Dietary Protocatechuic Acid (PCA) On The Function And Structure Of Participants With Prosthetic Joint Infection (PJI) Before Revision Surgery, As Measured By Standard Biomarkers

Proof of principle pilot study of the effect of dietary nutritional loading of protocatechunic acid (PCA) on the health and welfare of individuals with prosthetic joint infection (PJI), as measured by standard biomarkers

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Our purpose in the pre-surgery serial aspiration study is to determine the optimal PCA loading time duration for those with knee PJI with planned single or two stage revision.Our hypothesis, related to changes in structure and function as a result of PCA administration is that dietary nutritional loading of this nutraceutical PCA via the oral route will benefit the health and welfare of such a subject and alter the function and or structure of the human body having a PJI, as measured by improvemen in a pain biomarker, and one or more laboratory-based biomarkers.

Study Type

Interventional

Enrollment (Estimated)

10

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:

  • More than 3 weeks after total knee arthroplasty
  • One or more symptoms of injection, including redness, swelling, pain, increasing range of motion loss, fever, nausea, and loss of appetite.
  • WBC count of aspiration >50,0000 cells per μL

Exclusion Criteria:

- Not willing to undergo blood draw and joint needle aspiration weekly up to 4 weeks

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: Oral PCA
Dietary supplement: Oral PCA
Administration of 1,000 mg BID of oral PCA in individuals with knee prosthetic joint infection prior to revision surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Walking Pain 0-10 NRS
Time Frame: 0,1, 2, 3, and 4 weeks
Walking pain change from time 0 to weekly follow-ups from 1-4
0,1, 2, 3, and 4 weeks
Change in CRP
Time Frame: 0,1, 2, 3, and 4 weeks
Blood CRP change from time 0 to weekly follow-ups from 1-4
0,1, 2, 3, and 4 weeks
Change in ESR
Time Frame: 0,1, 2, 3, and 4 weeks
Blood ESR change from time 0 to weekly follow-ups from 1-4
0,1, 2, 3, and 4 weeks
Change in WBC count in aspirate
Time Frame: 0,1, 2, 3, and 4 weeks
Total WBC count change in periprosthetic aspirate
0,1, 2, 3, and 4 weeks
Bacterial colony count in aspirate
Time Frame: 0,1, 2, 3, and 4 weeks
Colony count graded as 0 (No colonies), 1 (Few colonies), 2 (moderate growth) 3(heavy growth), and 4 (too numerous to count)
0,1, 2, 3, and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CXCL9
Time Frame: 0 and 3 months
Change in Immunity Factor CXCL9 from 0 to 3 months
0 and 3 months
HbA1c
Time Frame: 0 and 3 months
Change in HbA1c from 0 to 3 months
0 and 3 months

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, 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)

March 1, 2025

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

December 1, 2025

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)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCALoading-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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