Intra-articular Platelet-Rich Plasma Compared With Viscosupplementation in the Treatment of Knee Osteoarthritis

NCT03491761 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: EH17-199
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cartilage Thickness on MRI

  Evaluation of changes from baseline in central medial femorotibial compartment cartilage thickness measurements (via ordered value method) using quantitative T1 and cartilage compositional changes using T2 MRI at 6 and 12 months.

  6 and 12 months

Secondary Outcomes (1)

• 3. A secondary outcome will be measuring changes in the KOOS Jr (Knee injury and Osteoarthritis Outcome Score)

  6 weeks, 12 weeks, 6 months, and 12 months

Study Arms (2)

PRP Treatment

EXPERIMENTAL

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.

Biological: PRP Treatment

HA Treatment

ACTIVE COMPARATOR

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.

Biological: HA Treatment

Interventions

PRP Treatment BIOLOGICAL

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.

Also known as: Platelet-Rich Plasma

PRP Treatment

HA Treatment BIOLOGICAL

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

Also known as: Hyaluronic Acid, Euflexxa

HA Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University HealthSystems

Skokie, Illinois, 60076, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Jason L Koh, MD, MBA

  Clinical Chairman, Dept. of Orthopaedics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason L Koh, MD, MBA

CONTACT

224-251-3481; jkoh@northshore.org

Sarah L Rabbitt, RN, BSN

CONTACT

847-933-6345; srabbitt@northshore.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Board of Directors Endowed Chair of Orthopaedic Surgery

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 9, 2018
• Study Start: June 13, 2018
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

US (1)