PCA Administration in Prosthetic Joint Infection | NCT06591741

Studies
PCA Administration in Prosthetic Joint Infection

NCT06591741

Sponsor

Dr. Dean Reeves Clinic

Status

Not yet recruiting

Last Update Posted

Aug 20, 2025Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Prosthetic Joint Infection

Interventions

Oral PCA

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2026Estimated

Primary Completion Date

Jul 2028Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

Sep 7, 2024

First Submission Date that Met QC Criteria

Sep 10, 2024

First Posted Date

Sep 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2025

Last Update Posted Date

Aug 20, 2025Actual

Name	Class
Lanny Johnson, M.D.	UNKNOWN
Leo Whiteside, M.D.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PCA administraton	Other		Dietary Supplement: Oral PCA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral PCA	Dietary Supplement	PCA 1,000 mg BID until surgery, held until anticoagulation, and resumed at 1,000 mg daily for 4 years	PCA administraton

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Reinfection rate after revision for prosthetic joint infection		0 to 4 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kenneth D Reeves, M.D.	Contact	9139637750		deanreevesMD@gmail.com
Lanny Johnson, M.D.	Contact	5172851812		drlannyjohnson@gmail.com

Overall Officials

Name	Affiliation	Role
Kenneth D Reeves, M.D.	K. Dean Reeves, M.D., P.A.	Principal Investigator

Locations

Not provided