OsteoarthritisNCT03460236
Precision Assessment of Platelet Rich Plasma for Joint Preservation
An observational study of Osteoarthritis, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Knee Osteoarthritis (OA) is a leading cause of premature disability in Veterans who develop knee OA at higher rates and younger ages than the population in general. For those with symptomatic early knee OA, who are years to decades away from meeting clinical indications for knee replacement surgery, knee injections… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Osteoarthritis
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2018to 31 Mar 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Symptomatic early knee osteoarthritis subjects who have elected to receive PRP treatment.
Who may be able to join
- symptomatic early knee OA
- full weight-bearing status
- have elected to receive PRP treatment
- Male veterans
- Female veterans
Who cannot join
- inflammatory arthritis, gout or recurrent pseudogout
- symptomatic OA of other lower extremity joints
- BMI >35 kg/m2
- use of walking, orthopedic, or prosthetic assistive device
- severe systemic disease defined as American Society of Anesthesiologists (ASA) 3 or above56
- inability to have MRI
- pregnant or intending to become pregnant during the study
- predominantly patellofemoral disease
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
About this study
Knee Osteoarthritis (OA) is a leading cause of premature disability in Veterans who develop knee OA at higher rates and younger ages than the population in general. For those with symptomatic early knee OA, who are years to decades away from meeting clinical indications for knee replacement surgery, knee injections have been a key treatment option. In recent years, platelet rich plasma (PRP) injections have gained increasing attention for improving pain and function in patients with knee OA. Basic science studies also suggest that PRP may also potentially stimulate repair responses to articular cartilage. However, the mechanisms of action of PRP in the treatment of knee OA are unknown. Because autologous blood is used, the PRP composition differs between patients. It is also unknown whether these differences in PRP composition affect clinical outcomes. This study will address these gaps and provide critical new and objective information on PRP treatment effects in Veterans and additional women with early knee OA important to improving clinical use of this new treatment.
Read the detailed description
Because very little is known about either the mechanisms of action or objective clinical outcomes of PRP treatment for knee OA, the investigators propose a prospective "pre-post" study that will permit us to identify areas where more rigorous clinical outcomes and mechanistic research may be warranted. The proposed work includes special elements of: (1) quantitative metrics to assess clinical outcomes, (2) correlation of candidate beneficial proteins with clinical outcomes, and (3) proteomic evaluation of the injected PRP. This work will use an innovative multi-disciplinary, personalized approach to evaluate the effects of PRP composition on both function, as assessed by patient-reported outcomes and gait analysis, and cartilage matrix structure as assessed by quantitative MRI
- Conditions
- Osteoarthritis
- Keywords
- PRP, osteoarthritis, MRI, gait, patient reported outcome
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PRP | Symptomatic early knee osteoarthritis subjects who have elected to receive PRP treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Knee Pain Improvement Over 6 Months Following PRP Injections
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain scores were determined through standardized questionnaires to evaluate osteoarthritis of the knee. The KOOS Pain scale consists of 9 questions with each response valued on an ordinal scale 0-4. KOOS Pain scores are transformed so that higher scores indicate less pain. Successful pain improvement is determined from the number of participants with changes in KOOS Pain in excess of the previously determined threshold of 12.4pts for minimal important change after non-surgical intervention for knee pain.
Measured: Baseline to 6 months
Number of Participants With Successful Knee Function Improvement Over 6 Months Following PRP Injections
Knee Function was determined from Western Ontario and McMaster University Osteoarthritis Index (WOMAC) scores, standardized questionnaires to evaluate osteoarthritis of the knee. The WOMAC Function scale consists of 17 questions, with each response valued on an ordinal scale of 0-4. Higher numbers indicate more physical disability. Successful functional improvement is determined from the number of participants with changes in the WOMAC Function score in excess of the previously determined threshold of -17pts for minimal important functional change after non-surgical intervention.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start2 Apr 2018
- Primary completion29 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Constance R. Chu, MD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460236
- Sponsor's protocol ID
- F2452-R
- Other IDs
- 43655
- Status last verified
- May 2025
- First submitted
- 10 Jan 2018
- Last updated
- 23 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Silva MDC, Perriman DM, Fearon AM, Couldrick JM, Scarvell JM. Minimal important change and difference for knee osteoarthritis outcome measurement tools after non-surgical interventions: a systematic review. BMJ Open. 2023 May 18;13(5):e063026. doi: 10.1136/bmjopen-2022-063026.
PubMed 37202126
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Assessment of Platelet Rich Plasma for Joint Preservation
- ClinicalTrials.gov ID
- NCT03460236
- Acronym / sponsor ID
- F2452-R
- Conditions
- Osteoarthritis
- Keywords
- PRP, osteoarthritis, MRI, gait, patient reported outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Posted 23 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Knee Osteoarthritis (OA) is a leading cause of premature disability in Veterans who develop knee OA at higher rates and younger ages than the population in general. For those with symptomatic early knee OA, who are years to decades away from meeting clinical indications for knee replacement surgery, knee injections have been a key treatment option. In recent years, platelet rich plasma (PRP) injections have gained increasing attention for improving pain and function in patients with knee OA. Basic science studies also suggest that PRP may also potentially stimulate repair responses to articular cartilage. However, the mechanisms of action of PRP in the treatment of knee OA are unknown. Because autologous blood is used, the PRP composition differs between patients. It is also unknown whether these differences in PRP composition affect clinical outcomes. This study will address these gaps and provide critical new and objective information on PRP treatment effects in Veterans and additional women with early knee OA important to improving clinical use of this new treatment.
Detailed description
Because very little is known about either the mechanisms of action or objective clinical outcomes of PRP treatment for knee OA, the investigators propose a prospective "pre-post" study that will permit us to identify areas where more rigorous clinical outcomes and mechanistic research may be warranted. The proposed work includes special elements of: (1) quantitative metrics to assess clinical outcomes, (2) correlation of candidate beneficial proteins with clinical outcomes, and (3) proteomic evaluation of the injected PRP. This work will use an innovative multi-disciplinary, personalized approach to evaluate the effects of PRP composition on both function, as assessed by patient-reported outcomes and gait analysis, and cartilage matrix structure as assessed by quantitative MRI
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRP | – | –Symptomatic early knee osteoarthritis subjects who have elected to receive PRP treatment. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic early knee osteoarthritis subjects who have elected to receive PRP treatment.
Key inclusion criteria (5 listed)
- symptomatic early knee OA
- full weight-bearing status
- have elected to receive PRP treatment
- Male veterans
- Female veterans
Key exclusion criteria (8 listed)
- inflammatory arthritis, gout or recurrent pseudogout
- symptomatic OA of other lower extremity joints
- BMI >35 kg/m2
- use of walking, orthopedic, or prosthetic assistive device
- severe systemic disease defined as American Society of Anesthesiologists (ASA) 3 or above56
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Successful Knee Pain Improvement Over 6 Months Following PRP Injections
Time frame: Baseline to 6 months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain scores were determined through standardized questionnaires to evaluate osteoarthritis of the knee. The KOOS Pain scale consists of 9 questions with each response valued on an ordinal scale 0-4. KOOS Pain scores are transformed so that higher scores indicate less pain. Successful pain improvement is determined from the number of participants with changes in KOOS Pain in excess of the previously determined threshold of 12.4pts for minimal important change after non-surgical intervention for knee pain.
Number of Participants With Successful Knee Function Improvement Over 6 Months Following PRP Injections
Time frame: Baseline to 6 months
Knee Function was determined from Western Ontario and McMaster University Osteoarthritis Index (WOMAC) scores, standardized questionnaires to evaluate osteoarthritis of the knee. The WOMAC Function scale consists of 17 questions, with each response valued on an ordinal scale of 0-4. Higher numbers indicate more physical disability. Successful functional improvement is determined from the number of participants with changes in the WOMAC Function score in excess of the previously determined threshold of -17pts for minimal important functional change after non-surgical intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37202126Silva MDC, Perriman DM, Fearon AM, Couldrick JM, Scarvell JM. Minimal important change and difference for knee osteoarthritis outcome measurement tools after non-surgical interventions: a systematic review. BMJ Open. 2023 May 18;13(5):e063026. doi: 10.1136/bmjopen-2022-063026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Constance R. Chu, MD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by VA Office of Research and Development at 1 site in United States.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 23 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Successful Knee Pain Improvement Over 6 Months Following PRP Injections (time frame: Baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03460236, which also lists 1 linked publication.
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 23 May 2025.