Osteoarthritis, KneePhase 2NCT05330689
How Does Platelet Dose Impact Clinical Outcomes After PRP Treatment?
A Phase 2 study testing PRP injection dose (<5 billion platelets), PRP injection dose (between 5 and <10 billion platelets) and PRP injection dose (between 10 and <20 billion platelets) in people with Osteoarthritis, Knee, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine which platelet rich plasma (PRP) injection dosage provides the most improvement in a patient's knee pain level at 26 weeks post-injection. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- PRP injection dose (<5 billion platelets), PRP injection dose (between 5 and <10 billion platelets) and PRP injection dose (between 10 and <20 billion platelets)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2022to 7 Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40-80 years of age
- Previous diagnosis of unilateral, primary osteoarthritis of the knee
- Knee pain; duration of symptoms > 4 weeks
- K-L grade 0-4
Who cannot join
- Under 40 years of age; over 80 years of age
- Bilateral knee pain
- Duration of symptoms < 4 weeks
- NSAID or clopidogrel use in the last 7 days
- High risk of a thrombotic event if discontinuing NSAID or clopidogrel for four weeks.
- Steroid use in the last 6 weeks
- Active diagnosis of leukopenia/anemia/thrombocytopenia
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The purpose of this study is to determine which platelet rich plasma (PRP) injection dosage provides the most improvement in a patient's knee pain level at 26 weeks post-injection.
Read the detailed description
Knee osteoarthritis (OA) is a chronic progressive disease affecting more than 20% of people older than 45 years. A myriad of different treatments have been proposed in the scientific literature, and current treatment options include conservative and surgical procedures in which the main objective is to relieve pain and improve function.
Conservative nonsurgical interventions include weight management, physical therapy, analgesics, nonsteroidal anti-inflammatory drugs (NSAIDS), corticosteroid and hyaluronic acid injections. Although these agents have been beneficial in the short term, there is a lack of evidence that such interventions alter the progression of OA. More recently, platelet-rich plasma (PRP), a biological therapy, has become an emerging treatment option to improve the status of the joint for patients with OA.
PRP is an autologous blood product that is injected into the knee joint, which contains an elevated concentration of platelets above that of whole blood. However, the optimal PRP preparation is still unknown. Studies are needed that investigate optimal platelet count and how that is related to clinical outcome.
This study is designed as a double-blind randomized controlled study, where enrolled subjects are randomized to one of five treatment groups (in blocks of 10):
- a total PRP injection dose of less than 5 billion platelets;
- a total PRP injection dose between 5 and <10 billion platelets;
- a total PRP injection dose between 10 and <20 billion platelets;
- a total PRP injection dose of >20 billion platelets; and
- a saline injection control
Each patient will be asked to complete a questionnaire at baseline, 6, 12, and 26 weeks.
After patients have completed all the study questionnaires, the Investigators will pull the results from the blood analysis, so that blood composition levels can be correlated with any pain improvements that are felt. The purpose of the study is to establish if there is a relationship between the injection dosage a patient receives and knee pain level (based on the pain scores from the self-reported questionnaire).
- Conditions
- Osteoarthritis, Knee
- Being tested
- PRP injection dose (<5 billion platelets), PRP injection dose (between 5 and <10 billion platelets), PRP injection dose (between 10 and <20 billion platelets), PRP injection dose (20 billion or greater platelets), Saline injection control
- Keywords
- Osteoarthritis, Osteoarthritis, Knee, Arthritis, Platelet rich plasma
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP injection dose (<5 billion platelets)Biological
PRP injection with a dose of platelets that is less than 5 billion platelets
PRP injection dose (between 5 and <10 billion platelets)Biological
PRP injection with a dose of platelets that is between 5 and <10 billion platelets
PRP injection dose (between 10 and <20 billion platelets)Biological
PRP injection with a dose of platelets that is between 10 and <20 billion platelets
PRP injection dose (20 billion or greater platelets)Biological
PRP injection with a dose of platelets that is 20 billion platelets or greater
Saline injection controlOther
Saline control
| Study group | Role | What they receive |
|---|---|---|
| Sample group 1 | Active comparator | Sample of subjects with primary osteoarthritis of the knee Receives: Biological: PRP injection dose (<5 billion platelets) |
| Sample group 2 | Active comparator | Sample of subjects with primary osteoarthritis of the knee Receives: Biological: PRP injection dose (between 5 and <10 billion platelets) |
| Sample group 3 | Active comparator | Sample of subjects with primary osteoarthritis of the knee Receives: Biological: PRP injection dose (between 10 and <20 billion platelets) |
| Sample group 4 | Active comparator | Sample of subjects with primary osteoarthritis of the knee Receives: Biological: PRP injection dose (20 billion or greater platelets) |
| Sample group 5 | Placebo comparator | Sample of subjects with primary osteoarthritis of the knee Receives: Other: Saline injection control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome measure: Consists of 5 subscales, one of which is "Pain". A normalized score (100 indicating no pain and 0 indicating extreme pain) is calculated for this subscale.
Measured: Baseline to 26 weeks post injections
Western Ontario and McMaster University's Osteoarthritis Index (WOMAC)
Patient-reported outcome measure: The scores for each subscale are summed up, with a possible score range of 0-20 for Pain. Higher scores indicate worse pain.
Measured: Baseline to 26 weeks post injections
Secondary outcomes (1)
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a unidimensional measure of pain intensity. The scale is most commonly anchored by "no pain " (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).
Measured: Baseline, 6 weeks, 12 weeks, 26 weeks post injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start6 Mar 2022
- Primary completion7 Sep 2022
- Study completion7 Sep 2022
Why it stopped: Funding for study equipment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leon Scott, Vanderbilt University Medical Center
- Investigators
- Leon Scott, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330689
- Sponsor's protocol ID
- PRPTreatment
- Status last verified
- Mar 2024
- First submitted
- 9 Apr 2022
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does Platelet Dose Impact Clinical Outcomes After PRP Treatment?
- ClinicalTrials.gov ID
- NCT05330689
- Acronym / sponsor ID
- PRPTreatment
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Osteoarthritis, Knee, Arthritis, Platelet rich plasma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding for study equipment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 6 Mar 2022 (actual)
- Primary completion
- 7 Sep 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 15 Apr 2022 (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.
The purpose of this study is to determine which platelet rich plasma (PRP) injection dosage provides the most improvement in a patient's knee pain level at 26 weeks post-injection.
Detailed description
Knee osteoarthritis (OA) is a chronic progressive disease affecting more than 20% of people older than 45 years. A myriad of different treatments have been proposed in the scientific literature, and current treatment options include conservative and surgical procedures in which the main objective is to relieve pain and improve function.
Conservative nonsurgical interventions include weight management, physical therapy, analgesics, nonsteroidal anti-inflammatory drugs (NSAIDS), corticosteroid and hyaluronic acid injections. Although these agents have been beneficial in the short term, there is a lack of evidence that such interventions alter the progression of OA. More recently, platelet-rich plasma (PRP), a biological therapy, has become an emerging treatment option to improve the status of the joint for patients with OA.
PRP is an autologous blood product that is injected into the knee joint, which contains an elevated concentration of platelets above that of whole blood. However, the optimal PRP preparation is still unknown. Studies are needed that investigate optimal platelet count and how that is related to clinical outcome.
This study is designed as a double-blind randomized controlled study, where enrolled subjects are randomized to one of five treatment groups (in blocks of 10):
- a total PRP injection dose of less than 5 billion platelets;
- a total PRP injection dose between 5 and <10 billion platelets;
- a total PRP injection dose between 10 and <20 billion platelets;
- a total PRP injection dose of >20 billion platelets; and
- a saline injection control
Each patient will be asked to complete a questionnaire at baseline, 6, 12, and 26 weeks.
After patients have completed all the study questionnaires, the Investigators will pull the results from the blood analysis, so that blood composition levels can be correlated with any pain improvements that are felt. The purpose of the study is to establish if there is a relationship between the injection dosage a patient receives and knee pain level (based on the pain scores from the self-reported questionnaire).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sample group 1 | Active comparator | Biological: PRP injection dose (<5 billion platelets)Sample of subjects with primary osteoarthritis of the knee |
| Sample group 2 | Active comparator | Biological: PRP injection dose (between 5 and <10 billion platelets)Sample of subjects with primary osteoarthritis of the knee |
| Sample group 3 | Active comparator | Biological: PRP injection dose (between 10 and <20 billion platelets)Sample of subjects with primary osteoarthritis of the knee |
| Sample group 4 | Active comparator | Biological: PRP injection dose (20 billion or greater platelets)Sample of subjects with primary osteoarthritis of the knee |
| Sample group 5 | Placebo comparator | Other: Saline injection controlSample of subjects with primary osteoarthritis of the knee |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 40-80 years of age
- Previous diagnosis of unilateral, primary osteoarthritis of the knee
- Knee pain; duration of symptoms > 4 weeks
- K-L grade 0-4
Key exclusion criteria (7 listed)
- Under 40 years of age; over 80 years of age
- Bilateral knee pain
- Duration of symptoms < 4 weeks
- NSAID or clopidogrel use in the last 7 days
- High risk of a thrombotic event if discontinuing NSAID or clopidogrel for four 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 |
|---|---|---|
| PRP injection dose (<5 billion platelets)PRP injection with a dose of platelets that is less than 5 billion platelets | Biological | Sample group 1 |
| PRP injection dose (between 5 and <10 billion platelets)PRP injection with a dose of platelets that is between 5 and <10 billion platelets | Biological | Sample group 2 |
| PRP injection dose (between 10 and <20 billion platelets)PRP injection with a dose of platelets that is between 10 and <20 billion platelets | Biological | Sample group 3 |
| PRP injection dose (20 billion or greater platelets)PRP injection with a dose of platelets that is 20 billion platelets or greater | Biological | Sample group 4 |
| Saline injection controlSaline control | Other | Sample group 5 |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline to 26 weeks post injections
Patient reported outcome measure: Consists of 5 subscales, one of which is "Pain". A normalized score (100 indicating no pain and 0 indicating extreme pain) is calculated for this subscale.
Western Ontario and McMaster University's Osteoarthritis Index (WOMAC)
Time frame: Baseline to 26 weeks post injections
Patient-reported outcome measure: The scores for each subscale are summed up, with a possible score range of 0-20 for Pain. Higher scores indicate worse pain.
1 secondary outcome
Visual Analog Scale (VAS)
Time frame: Baseline, 6 weeks, 12 weeks, 26 weeks post injections
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- 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.
Leon Scott, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRP injection dose (<5 billion platelets), PRP injection dose (between 5 and <10 billion platelets) and PRP injection dose (between 10 and <20 billion platelets) in people with Osteoarthritis, Knee, run by Vanderbilt University Medical Center 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 4 inclusion and 7 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: withdrawn, as of the sponsor's last update on 26 Mar 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: Baseline to 26 weeks post injections). 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?
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 26 Mar 2024.