How Does Platelet Dose Impact Clinical Outcomes After PRP Treatment?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Sample group 1
Sample of subjects with primary osteoarthritis of the knee
|
PRP injection with a dose of platelets that is less than 5 billion platelets
|
|
Active Comparator: Sample group 2
Sample of subjects with primary osteoarthritis of the knee
|
PRP injection with a dose of platelets that is between 5 and <10 billion platelets
|
|
Active Comparator: Sample group 3
Sample of subjects with primary osteoarthritis of the knee
|
PRP injection with a dose of platelets that is between 10 and <20 billion platelets
|
|
Active Comparator: Sample group 4
Sample of subjects with primary osteoarthritis of the knee
|
PRP injection with a dose of platelets that is 20 billion platelets or greater
|
|
Placebo Comparator: Sample group 5
Sample of subjects with primary osteoarthritis of the knee
|
Saline control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline to 26 weeks post injections
|
|
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.
|
Baseline to 26 weeks post injections
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: Baseline, 6 weeks, 12 weeks, 26 weeks post injections
|
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).
|
Baseline, 6 weeks, 12 weeks, 26 weeks post injections
|
Collaborators and Investigators
Investigators
- Principal Investigator: Leon Scott, MD, Vanderbilt University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRPTreatment
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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