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PCA Administration in Prosthetic Joint Infection

Effects of Dietary Protocatechuic Acid (PCA) on the Function and Structure of Participants With Knee Prosthetic Joint Infection (PJI) as Measured by Standard Biomarkers

Status
Suspended
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06591741
Enrollment
100
Registered
2024-09-19
Start date
2027-01-01
Completion date
2028-12-01
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prosthetic Joint Infection

Brief summary

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_SUPPLEMENTOral PCA

PCA 1,000 mg BID until surgery, held until anticoagulation, and resumed at 1,000 mg daily for 4 years

Sponsors

Dr. Dean Reeves Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Change in immunity factor CXCL9 from 0 to 3 months0 and 3 months
Change in HbA1c from 0 to 3 months0 and 3 months

Secondary

MeasureTime frame
Reinfection rate after revision for prosthetic joint infection0 to 4 years

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKenneth D Reeves, M.D.

K. Dean Reeves, M.D., P.A.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026