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Not yet recruiting NCT06591741

PCA Administration in Prosthetic Joint Infection

No phase Interventional 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 →
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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗