How Does Platelet Dose Impact Clinical Outcomes After PRP Treatment?

Vanderbilt University Medical Center

Status and phase

Withdrawn

Phase 2

Conditions

Osteoarthritis, Knee

Treatments

Biological: PRP injection dose (between 5 and <10 billion platelets)

Biological: PRP injection dose (20 billion or greater platelets)

Biological: PRP injection dose (<5 billion platelets)

Biological: PRP injection dose (between 10 and <20 billion platelets)

Other: Saline injection control

Study type

Interventional

Funder types

Other

Identifiers

NCT05330689

PRPTreatment

Details and patient eligibility

About

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.

Full 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).

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 5 patient groups, including a placebo group

Sample group 1

Active Comparator group

Description: