Recruiting
Phase 2

Platelet-Rich Plasma & Viscosupplementation

Sponsor:

Endeavor Health

Code:

NCT03491761

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

PRP Treatment

HA Treatment

Study Details

Brief 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.

Conditions

Knee Osteoarthritis

Study ID

NCT03491761

Start date

Jun 13, 2018

Status verified date

Feb, 2024

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Presence of major axial deformity (>5° valgus or varus deviation)
  • Surgery on target knee within 12 months prior to scheduled treatment
  • Autoimmune disorder
  • Active infections
  • Immuno-suppression (e.g., AIDS, etc.)
  • Anti-coagulant therapy
  • Use of NSAIDs 5 days prior to blood draw or up to 7 days after last PRP / HA treatment
  • Hemoglobin (Hg) <12 g/dL
  • Platelet counts (PLT) <150,000 /mm3
  • Previous infiltrative treatment within 3 weeks prior to scheduled treatment
  • Pregnancy/Breastfeeding
  • Hypersensitivity to HA
  • Inability to complete an MRI due to metal implants or claustrophobia
  • Diabetes
  • Active treatment for a malignancy
  • Active wound in the knee
  • Recent history of knee trauma
  • Vasovagal history
  • An injection of hyaluronic acid (HA) or platelet-rich plasma (PRP) to the affected knee within the last two years.
  • In the judgment of the investigator, the patient is unable to perform and/or complete all of the study visits or treatments required.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

PRP Treatment

PRP will be prepared using an Arthrex ACP® kit (a low-leukocyte Autologous Conditioned Plasma system). This is a single-spin system that concentrates platelets and separates red blood cells (RBCs) as well as white blood cells (WBCs) from the treatment product.

HA Treatment

Euflexxa will be used for treatment. It will be prepared according to the package insert.

Primary outcome measure

  • Cartilage Thickness on MRI [ Time Frame: 6 and 12 months ]

Central Contacts and Locations

Central contacts

Jason L Koh, MD, MBA

224-251-3481jkoh@northshore.org

Sarah L Rabbitt, RN, BSN

847-933-6345srabbitt@northshore.org

Locations

NorthShore University HealthSystems

Recruiting

Skokie, Illinois, United States, 60076

Contacts

Jason L Koh, MD, MBA

847-866-7846jkoh@northshore.org

Principal Investigator:

Jason L Koh, MD, MBA

More Information

Sponsor

Endeavor Health

Last update posted

Feb 28, 2024

Last verified

Feb, 2024

Keywords

  • Platelet Rich Plasma (PRP)
  • Viscosupplementation
  • Knee Osteoarthritis
  • Hyaluronic Acid (HA)
  • WOMAC
  • KOOS
  • Euflexxa

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endeavor Health on 2024-02-28.