How Does Platelet Dose Impact Clinical Outcomes After PRP 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.

Study Overview

• Status: Withdrawn
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Biological: PRP injection dose (<5 billion platelets); Biological: PRP injection dose (between 5 and <10 billion platelets); Biological: PRP injection dose (between 10 and <20 billion platelets); Biological: PRP injection dose (20 billion or greater platelets); Other: Saline injection control

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):

1. a total PRP injection dose of less than 5 billion platelets;
2. a total PRP injection dose between 5 and <10 billion platelets;
3. a total PRP injection dose between 10 and <20 billion platelets;
4. a total PRP injection dose of >20 billion platelets; and
5. 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: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sample group 1; Sample of subjects with primary osteoarthritis of the knee	Biological: PRP injection dose (<5 billion platelets); 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	Biological: PRP injection dose (between 5 and <10 billion platelets); 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	Biological: PRP injection dose (between 10 and <20 billion platelets); 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	Biological: PRP injection dose (20 billion or greater platelets); 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	Other: Saline injection control; Saline control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline to 26 weeks post injections

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, 6 weeks, 12 weeks, 26 weeks post injections

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Leon Scott, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2022
• Primary Completion (Actual): September 7, 2022
• Study Completion (Actual): September 7, 2022

Study Registration Dates

• First Submitted: April 9, 2022
• First Submitted That Met QC Criteria: April 9, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 24, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Arthritis; Osteoarthritis; Platelet rich plasma; Osteoarthritis, Knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: PRPTreatment

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No