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| Name | Class |
|---|---|
| Lanny Johnson, M.D. | UNKNOWN |
| Leo Whiteside, M.D. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral PCA | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral PCA | Dietary Supplement | Administration of 1,000 mg BID of oral PCA in individuals with knee prosthetic joint infection prior to revision surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| CXCL9 | Change in Immunity Factor CXCL9 from 0 to 3 months | 0 and 3 months |
| HbA1c | Change in HbA1c from 0 to 3 months | 0 and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
- Not willing to undergo blood draw and joint needle aspiration weekly up to 4 weeks
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kenneth D Reeves, M.D. | Contact | 9139637750 | deanreevesMD@gmail.com | |
| Lanny Johnson, M.D. | Contact | 5172851812 | drlannyjohnson@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kenneth D Reeves | K. Dean Reeves, M.D., P.A. | Principal Investigator |
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| ID | Term |
|---|---|
| D016459 | Prosthesis-Related Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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