Prosthesis-Related InfectionsNCT06591728
PCA Loading Time Before Knee Prosthetic Joint Infection Revision
A study testing Oral PCA in people with Prosthesis-Related Infections, run by Dr. Dean Reeves Clinic.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Prosthesis-Related Infections
- What is being tested?
- Oral PCA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not willing to undergo blood draw and joint needle aspiration weekly up to 4 weeks
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effects Of Dietary Protocatechuic Acid (PCA) On The Function And Structure Of Participants With Prosthetic Joint Infection (PJI) Before Revision Surgery, As Measured By Standard Biomarkers
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
Read the detailed 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.
- Conditions
- Prosthesis-Related Infections
- Being tested
- Oral PCA
- Medical subject headings
- Prosthesis-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral PCADietary supplement
Administration of 1,000 mg BID of oral PCA in individuals with knee prosthetic joint infection prior to revision surgery
| Study group | Role | What they receive |
|---|---|---|
| Oral PCA | Other | Not described Receives: Dietary Supplement: Oral PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Walking Pain 0-10 NRS
Walking pain change from time 0 to weekly follow-ups from 1-4
Measured: 0,1, 2, 3, and 4 weeks
Change in CRP
Blood CRP change from time 0 to weekly follow-ups from 1-4
Measured: 0,1, 2, 3, and 4 weeks
Change in ESR
Blood ESR change from time 0 to weekly follow-ups from 1-4
Measured: 0,1, 2, 3, and 4 weeks
Change in WBC count in aspirate
Total WBC count change in periprosthetic aspirate
Measured: 0,1, 2, 3, and 4 weeks
Bacterial colony count in aspirate
Colony count graded as 0 (No colonies), 1 (Few colonies), 2 (moderate growth) 3(heavy growth), and 4 (too numerous to count)
Measured: 0,1, 2, 3, and 4 weeks
Secondary outcomes (2)
CXCL9
Change in Immunity Factor CXCL9 from 0 to 3 months
Measured: 0 and 3 months
HbA1c
Change in HbA1c from 0 to 3 months
Measured: 0 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Mar 2025 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis-Related InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Dean Reeves Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Lanny Johnson, M.D., Leo Whiteside, M.D.
- Responsible party
- Principal investigator, Dr. Dean Reeves, Dr. Dean Reeves Clinic
- Investigators
- Kenneth D Reeves, Principal investigator, K. Dean Reeves, M.D., P.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591728
- Sponsor's protocol ID
- PCALoading-01
- Status last verified
- Feb 2025
- First submitted
- 7 Sep 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Dietary Protocatechuic Acid (PCA) On The Function And Structure Of Participants With Prosthetic Joint Infection (PJI) Before Revision Surgery, As Measured By Standard Biomarkers
- ClinicalTrials.gov ID
- NCT06591728
- Acronym / sponsor ID
- PCALoading-01
- Conditions
- Prosthesis-Related Infections
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Dr. Dean Reeves ClinicUniversity, hospital or other
- Collaborators
- Lanny Johnson, M.D., Leo Whiteside, M.D.
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral PCA | Other | Dietary Supplement: Oral PCA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Not willing to undergo blood draw and joint needle aspiration weekly up to 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral PCAAdministration of 1,000 mg BID of oral PCA in individuals with knee prosthetic joint infection prior to revision surgery | Dietary supplement | Oral PCA |
Primary outcome
Change in Walking Pain 0-10 NRS
Time frame: 0,1, 2, 3, and 4 weeks
Walking pain change from time 0 to weekly follow-ups from 1-4
Change in CRP
Time frame: 0,1, 2, 3, and 4 weeks
Blood CRP change from time 0 to weekly follow-ups from 1-4
Change in ESR
Time frame: 0,1, 2, 3, and 4 weeks
Blood ESR change from time 0 to weekly follow-ups from 1-4
Change in WBC count in aspirate
Time frame: 0,1, 2, 3, and 4 weeks
Total WBC count change in periprosthetic aspirate
Bacterial colony count in aspirate
Time frame: 0,1, 2, 3, and 4 weeks
Colony count graded as 0 (No colonies), 1 (Few colonies), 2 (moderate growth) 3(heavy growth), and 4 (too numerous to count)
2 secondary outcomes
CXCL9
Time frame: 0 and 3 months
HbA1c
Time frame: 0 and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kenneth D Reeves principal investigator
K. Dean Reeves, M.D., P.A.
Questions about this trial
What is this clinical trial studying?
A study testing Oral PCA in people with Prosthesis-Related Infections, run by Dr. Dean Reeves Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kenneth D Reeves, M.D. (9139637750, deanreevesMD@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Walking Pain 0-10 NRS (time frame: 0,1, 2, 3, and 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.