PCA Loading Time Before Knee Prosthetic Joint Infection Revision

NCT06591728 | Not Yet Recruiting

• 1 other identifier: PCALoading-01
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Prosthesis-Related Infections

Outcome Measures

Primary Outcomes (5)

• Change in Walking Pain 0-10 NRS

  Walking pain change from time 0 to weekly follow-ups from 1-4

  0,1, 2, 3, and 4 weeks

• Change in CRP

  Blood CRP change from time 0 to weekly follow-ups from 1-4

  0,1, 2, 3, and 4 weeks

• Change in ESR

  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

  Total WBC count change in periprosthetic aspirate

  0,1, 2, 3, and 4 weeks

• Bacterial colony count in aspirate

  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 Outcomes (2)

• CXCL9

  0 and 3 months

• HbA1c

  0 and 3 months

Study Arms (1)

Oral PCA

OTHER

Dietary Supplement: Oral PCA

Interventions

Oral PCA DIETARY_SUPPLEMENT

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

Oral PCA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Dean Reeves Clinic: lead
• Lanny Johnson, M.D.: collaborator
• Leo Whiteside, M.D.: collaborator

MeSH Terms

Conditions

Prosthesis-Related Infections

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kenneth D Reeves

  K. Dean Reeves, M.D., P.A.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth D Reeves, M.D.

CONTACT

9139637750; deanreevesMD@gmail.com

Lanny Johnson, M.D.

CONTACT

5172851812; drlannyjohnson@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2024
• First Posted: September 19, 2024
• Study Start: March 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-02