PCA Administration in Prosthetic Joint Infection
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: Prosthetic Joint Infection. 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
Effects of Dietary Protocatechuic Acid (PCA) on the Function and Structure of Participants With Knee Prosthetic Joint Infection (PJI) as Measured by Standard Biomarkers
Overview
Determine if dietary protocatechuic acid (PCA) will affect health biomarkers in patient undergoing revision surgery for a knee prosthetic joint infection
Detailed description
Patients who are scheduled to undergo revision surgery for a knee prosthetic joint infection are given PCA prior to surgery for a time period determined by a previous pilot study. PCA is then post-operatively until anticoagulation is stopped, and then will be resumed for four years post revision surgery. Measurement of changes in glucose control, immunity, will be measured over the first 3 months post-revision, and the post-revision reinfection rate over the full 4 years will be compared to a cohort rate
Interventions
- Dietary supplement Oral PCA
PCA 1,000 mg BID until surgery, held until anticoagulation, and resumed at 1,000 mg daily for 4 years
Primary outcome measures
- Change in immunity factor CXCL9 from 0 to 3 months [Time frame: 0 and 3 months]
- Change in HbA1c from 0 to 3 months [Time frame: 0 and 3 months]
Secondary outcome measures (1)
- Reinfection rate after revision for prosthetic joint infection [Time frame: 0 to 4 years]
Eligibility criteria
Inclusion criteria
- 3 weeks or more after total knee arthroplasty
- One or more symptoms of infection, including redness, swelling, pain, increasing range of motion loss, fever, nausea, and loss of appetite.
- WBC count of aspirate >50,000 cells per μL
Exclusion criteria
- Not willing to undergo blood draw at 3 months.
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: NCT06591741 · PCAinPJI-01