Does Intra-articular Platelet-Rich Plasma Injection Provide Superior Outcomes Compared With Viscosupplementation in the Treatment of Knee Osteoarthritis?

Who is this study for? Adult patients with Knee Osteoarthritis
What treatments are being studied? Platelet-Rich Plasma
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a single-center, prospective, randomized, single-blind, comparator therapy, parallel group study for symptomatic patients diagnosed with knee osteoarthritis. The aim is to demonstrate superior efficacy of platelet-rich plasma (PRP) as compared to hyaluronic acid (HA) in treating knee osteoarthritis. This aim will be objectively measured by endpoint consisting of changes in cartilage thickness from baseline in the MRI. The Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire will be used to calculate The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score. It will measure changes in pain and function from baseline. Approximately 100 subjects will be treated at NorthShore University HealthSystem (NorthShore) as part of this study. This study has the potential to improve outcomes in a very common chronic degenerative disease, osteoarthritis, which can have a significant effect on individuals' quality of life.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Ability to provide informed consent

• Chronic pain (\>3 months)

• Grade 2 -3 according to Kellgren- Lawrence (K-L) classification system (using bilateral anteroposterior radiograph image acquired while the patient is weight-bearing with both knees in full extension)

• Minimum score of 40 out of possible 100 on the VAS (Visual Analog Scale) for pain

• Age 18 to 75 years old

• Physical exam and medical history

• Complete Blood Count to include platelets and differential (CBC with Diff) within normal limits

• C-Reactive Protein (CRP) within normal limits

• Sed Rate (ESR) within normal limits

• Survey of current medications

Locations
United States
Illinois
NorthShore University HealthSystems
RECRUITING
Skokie
Contact Information
Primary
Jason L Koh, MD, MBA
jkoh@northshore.org
224-251-3481
Backup
Sarah L Rabbitt, RN, BSN
srabbitt@northshore.org
847-933-6345
Time Frame
Start Date: 2018-06-13
Estimated Completion Date: 2027-12
Participants
Target number of participants: 100
Treatments
Experimental: PRP Treatment
PRP is injected using 22 gauge needles through the classic approach (lateral midpatellar) in a sterile setting. The PRP is obtained from a maximum 16 cc sample of the patients' blood drawn at the time of treatment. Using sterile technique, the venous blood is transferred to a centrifuge and prepared by the centrifugation process for 5 minutes. 4-7 mL of PRP is transferred from the large outer syringe into the small inner syringe and injected within 30 minutes of being spun to negate the need of anticoagulants. The procedure will take approximately 20-30 minutes.
Active_comparator: HA Treatment
HA is injected using 22 gauge needles through the classic approach (lateral midpatellar) in a sterile setting. Euflexxa will be prepared according to the package insert.
Related Therapeutic Areas
Sponsors
Leads: Endeavor Health

This content was sourced from clinicaltrials.gov