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PCA Administration in Prosthetic Joint Infection

D

Dr. Dean Reeves Clinic

Status

Not yet enrolling

Conditions

Prosthetic Joint Infection

Treatments

Dietary Supplement: Oral PCA

Study type

Interventional

Funder types

Other

Identifiers

NCT06591741
PCAinPJI-01

Details and patient eligibility

About

Determine if dietary protocatechuic acid (PCA) will affect health biomarkers in patient undergoing revision surgery for a knee prosthetic joint infection

Full 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

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

PCA administraton
Other group
Treatment:
Dietary Supplement: Oral PCA

Trial contacts and locations

0

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Central trial contact

Kenneth D Reeves, M.D.; Lanny Johnson, M.D.

Data sourced from clinicaltrials.gov

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