A Phase 2 interventional study of PRP injection dose (<5 billion platelets) and PRP injection dose (between 5 and <10 billion platelets) in Osteoarthritis, Knee, sponsored by Vanderbilt University Medical Center. Withdrawn at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-26.
Sponsored by Vanderbilt University Medical Center · Phase 2, Interventional, and Treatment
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.
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):
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).
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
Browse Osteoarthritis studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sample of subjects with primary osteoarthritis of the knee
Biological: PRP injection dose (<5 billion platelets)
Sample of subjects with primary osteoarthritis of the knee
Biological: PRP injection dose (between 5 and <10 billion platelets)
Sample of subjects with primary osteoarthritis of the knee
Biological: PRP injection dose (between 10 and <20 billion platelets)
Sample of subjects with primary osteoarthritis of the knee
Biological: PRP injection dose (20 billion or greater platelets)
Sample of subjects with primary osteoarthritis of the knee
Other: Saline injection control
PRP injection with a dose of platelets that is less than 5 billion platelets
PRP injection with a dose of platelets that is between 5 and \<10 billion platelets
PRP injection with a dose of platelets that is between 10 and \<20 billion platelets
PRP injection with a dose of platelets that is 20 billion platelets or greater
Saline control
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.
Time frame: 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.
Time frame: Baseline to 26 weeks post injections
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).
Time frame: Baseline, 6 weeks, 12 weeks, 26 weeks post injections
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vanderbilt University Medical Center