Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT03491761

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

Led by Endeavor Health · Updated on 2024-02-28

100

Participants Needed

1

Research Sites

494 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to provide informed consent
  • Chronic knee pain lasting more than 3 months
  • Kellgren-Lawrence grade 2 or 3 knee osteoarthritis
  • Minimum pain score of 40 out of 100 on the Visual Analog Scale
  • Age between 18 and 75 years old
  • Physical exam and medical history consistent with study requirements
  • Complete Blood Count (CBC) with differential within normal limits
  • C-Reactive Protein (CRP) within normal limits
  • Sedimentation Rate (ESR) within normal limits
  • Current medication survey completed
Not Eligible

You will not qualify if you...

  • Major axial deformity greater than 5 degrees valgus or varus
  • Knee surgery on target knee within 12 months prior to treatment
  • Autoimmune disorders
  • Active infections
  • Immunosuppression (e.g., AIDS)
  • Use of anticoagulant therapy
  • Use of NSAIDs within 5 days before blood draw or up to 7 days after treatment
  • Hemoglobin less than 12 g/dL
  • Platelet count less than 150,000/mm3
  • Previous infiltrative treatment within 3 weeks prior to treatment
  • Pregnancy or breastfeeding
  • Allergy to hyaluronic acid
  • Unable to complete MRI due to metal implants or claustrophobia
  • Diabetes
  • Active cancer treatment
  • Active knee wound
  • Recent knee trauma
  • History of vasovagal reactions
  • Hyaluronic acid or PRP injection in affected knee within last 2 years
  • Inability to complete all study visits or treatments as judged by investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

NorthShore University HealthSystems

Skokie, Illinois, United States, 60076

Actively Recruiting

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Research Team

J

Jason L Koh, MD, MBA

CONTACT

S

Sarah L Rabbitt, RN, BSN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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