The Effects Of Dietary Protocatechuic Acid (PCA) On The Function And Structure Of Participants With Prosthetic Joint Infection (PJI) Before Revision Surgery, As Measured By Standard Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 主要终点
- Change in Walking Pain 0-10 NRS
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Not willing to undergo blood draw and joint needle aspiration weekly up to 4 weeks
结局指标
主要结局
Change in Walking Pain 0-10 NRS
时间窗: 0,1, 2, 3, and 4 weeks
Walking pain change from time 0 to weekly follow-ups from 1-4
Change in CRP
时间窗: 0,1, 2, 3, and 4 weeks
Blood CRP change from time 0 to weekly follow-ups from 1-4
Change in ESR
时间窗: 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
时间窗: 0,1, 2, 3, and 4 weeks
Total WBC count change in periprosthetic aspirate
Bacterial colony count in aspirate
时间窗: 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)
次要结局
- CXCL9(0 and 3 months)
- HbA1c(0 and 3 months)
研究者
Dr. Dean Reeves
Principal Investigator
Dr. Dean Reeves Clinic