Prosthesis-Related Infections
Conditions
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.
Interventions
DIETARY_SUPPLEMENTOral PCA
Administration of 1,000 mg BID of oral PCA in individuals with knee prosthetic joint infection prior to revision surgery
Sponsors
Lanny Johnson, M.D.
Leo Whiteside, M.D.
Dr. Dean Reeves Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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) |
| 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 ESR | 0,1, 2, 3, and 4 weeks | Blood ESR change from time 0 to weekly follow-ups from 1-4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 0 and 3 months | Change in HbA1c from 0 to 3 months |
| CXCL9 | 0 and 3 months | Change in Immunity Factor CXCL9 from 0 to 3 months |
Contacts
Primary ContactKenneth D Reeves, M.D.
Backup ContactLanny Johnson, M.D.
Outcome results
None listed