PCA Loading Time Before Knee Prosthetic Joint Infection Revision

Not Applicable

Not yet recruiting

• Conditions: Prosthesis-Related Infections
• Interventions: Dietary Supplement: Oral PCA

• Registration Number: NCT06591728
• Lead Sponsor: Dr. Dean Reeves Clinic

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

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 Timeline

• Study First Submitted: 2024-09-07
• Study First Submitted QC: 2024-09-10
• Study First Posted: 2024-09-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-05
• Study Start: 2025-03-01
• Primary Completion: 2025-08
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral PCA	Oral PCA	-

Primary Outcome Measures

Name	Time	Method
Change in Walking Pain 0-10 NRS	0,1, 2, 3, and 4 weeks	Walking pain change from time 0 to weekly follow-ups from 1-4
Change in CRP	0,1, 2, 3, and 4 weeks	Blood CRP change from time 0 to weekly follow-ups from 1-4
Change in ESR	0,1, 2, 3, and 4 weeks	Blood ESR change from time 0 to weekly follow-ups from 1-4
Change in WBC count in aspirate	0,1, 2, 3, and 4 weeks	Total WBC count change in periprosthetic aspirate
Bacterial colony count in aspirate	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 Outcome Measures

Name	Time	Method
CXCL9	0 and 3 months	Change in Immunity Factor CXCL9 from 0 to 3 months
HbA1c	0 and 3 months	Change in HbA1c from 0 to 3 months