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NCT Number: NCT06591728

PCA Loading Time Before Knee Prosthetic Joint Infection Revision

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

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Key information

Conditions

Prosthesis-Related Infections Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral PCA

Dietary Supplement

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. Change in WBC count in aspirate

    Time frame: 0,1, 2, 3, and 4 weeks

    Total WBC count change in periprosthetic aspirate

  5. 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)

Secondary outcomes

  1. CXCL9

    Time frame: 0 and 3 months

    Change in Immunity Factor CXCL9 from 0 to 3 months

  2. HbA1c

    Time frame: 0 and 3 months

    Change in HbA1c from 0 to 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Kenneth D Reeves, M.D.

CONTACT

[email protected]

9139637750

Lanny Johnson, M.D.

CONTACT

[email protected]

5172851812

Sponsors and collaborators

Lead sponsor

Dr. Dean Reeves Clinic

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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