PCA Loading Time Before Knee Prosthetic Joint Infection Revision

Dr. Dean Reeves Clinic

Status: Not yet enrolling

Conditions: Prosthesis-Related Infections

Treatments: Dietary Supplement: Oral PCA

Study type: Interventional

Funder types: Other

Identifiers

NCT06591728

PCALoading-01

Details and patient eligibility

About

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

Full description

Our purpose in the pre-surgery serial aspiration study is to determine the optimal PCA loading time duration for those with knee PJI with planned single or two stage revision.Our hypothesis, related to changes in structure and function as a result of PCA administration is that dietary nutritional loading of this nutraceutical PCA via the oral route will benefit the health and welfare of such a subject and alter the function and or structure of the human body having a PJI, as measured by improvemen in a pain biomarker, and one or more laboratory-based biomarkers.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Not willing to undergo blood draw and joint needle aspiration weekly up to 4 weeks

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Oral PCA

Other group

Treatment:

Dietary Supplement: Oral PCA