PCA Loading Time Before Knee Prosthetic Joint Infection Revision
ConditionProsthesis-Related Infections
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorDr. Dean Reeves Clinic
About this trial
Proof of principle pilot study of the effect of dietary nutritional loading of protocatechunic acid (PCA) on the health and welfare of individuals with prosthetic joint infection (PJI), as measured by standard biomarkers
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
More than 3 weeks after total knee arthroplasty
One or more symptoms of injection, including redness, swelling, pain, increasing range of motion loss, fever, nausea, and loss of appetite.
WBC count of aspiration >50,0000 cells per μL
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Oral PCA
Dietary supplementAdministration of 1,000 mg BID of oral PCA in individuals with knee prosthetic joint infection prior to revision surgery
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Oral PCAOther 1 intervention
Trial outcomes
Primary outcomes
1
Change in Walking Pain 0-10 NRS
Walking pain change from time 0 to weekly follow-ups from 1-4
Time frame
0,1, 2, 3, and 4 weeks2
Change in CRP
Blood CRP change from time 0 to weekly follow-ups from 1-4
Time frame
0,1, 2, 3, and 4 weeks3
Change in ESR
Blood ESR change from time 0 to weekly follow-ups from 1-4
Time frame
0,1, 2, 3, and 4 weeks4
Change in WBC count in aspirate
Total WBC count change in periprosthetic aspirate
Time frame
0,1, 2, 3, and 4 weeksSecondary outcomes
1
CXCL9
Change in Immunity Factor CXCL9 from 0 to 3 months
Time frame
0 and 3 months2
HbA1c
Change in HbA1c from 0 to 3 months
Time frame
0 and 3 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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