PCA Administration in Prosthetic Joint Infection
Not Applicable
Not yet recruiting
- Conditions
- Prosthetic Joint Infection
- Interventions
- Dietary Supplement: Oral PCA
- Registration Number
- NCT06591741
- Lead Sponsor
- Dr. Dean Reeves Clinic
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PCA administraton Oral PCA -
- Primary Outcome Measures
Name Time Method Change in immunity factor CXCL9 from 0 to 3 months 0 and 3 months Change in HbA1c from 0 to 3 months 0 and 3 months
- Secondary Outcome Measures
Name Time Method Reinfection rate after revision for prosthetic joint infection 0 to 4 years