PCA Loading Time Before Knee Prosthetic Joint Infection Revision
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oral PCA.
- Who it may be relevant to
- Registry conditions: Prosthesis-Related Infections. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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 supplement Oral PCA
Administration of 1,000 mg BID of oral PCA in individuals with knee prosthetic joint infection prior to revision surgery
Primary outcome measures
- Change in Walking Pain 0-10 NRS [Time frame: 0,1, 2, 3, and 4 weeks]
- Change in CRP [Time frame: 0,1, 2, 3, and 4 weeks]
- Change in ESR [Time frame: 0,1, 2, 3, and 4 weeks]
- Change in WBC count in aspirate [Time frame: 0,1, 2, 3, and 4 weeks]
- Bacterial colony count in aspirate [Time frame: 0,1, 2, 3, and 4 weeks]
Secondary outcome measures (2)
- CXCL9 [Time frame: 0 and 3 months]
- HbA1c [Time frame: 0 and 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06591728 · PCALoading-01