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
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
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
Administration of 1,000 mg BID of oral PCA in individuals with knee prosthetic joint infection prior to revision surgery
Change in Walking Pain 0-10 NRS
Walking pain change from time 0 to weekly follow-ups from 1-4
Time frame: 0,1, 2, 3, and 4 weeks
Change in CRP
Blood CRP change from time 0 to weekly follow-ups from 1-4
Time frame: 0,1, 2, 3, and 4 weeks
Change in ESR
Blood ESR change from time 0 to weekly follow-ups from 1-4
Time frame: 0,1, 2, 3, and 4 weeks
Change in WBC count in aspirate
Total WBC count change in periprosthetic aspirate
Time frame: 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)
Time frame: 0,1, 2, 3, and 4 weeks
CXCL9
Change in Immunity Factor CXCL9 from 0 to 3 months
Time frame: 0 and 3 months
HbA1c
Change in HbA1c from 0 to 3 months
Time frame: 0 and 3 months
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