RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-06-13
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03491761

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to provide informed consent
  2. * Chronic pain (\>3 months)
  3. * 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)
  4. * Minimum score of 40 out of possible 100 on the VAS (Visual Analog Scale) for pain
  5. * Age 18 to 75 years old
  6. * Physical exam and medical history
  7. * Complete Blood Count to include platelets and differential (CBC with Diff) within normal limits
  8. * C-Reactive Protein (CRP) within normal limits
  9. * Sed Rate (ESR) within normal limits
  10. * Survey of current medications
  1. * Presence of major axial deformity (\>5° valgus or varus deviation)
  2. * Surgery on target knee within 12 months prior to scheduled treatment
  3. * Autoimmune disorder
  4. * Active infections
  5. * Immuno-suppression (e.g., AIDS, etc.)
  6. * Anti-coagulant therapy
  7. * Use of NSAIDs 5 days prior to blood draw or up to 7 days after last PRP / HA treatment
  8. * Hemoglobin (Hg) \<12 g/dL
  9. * Platelet counts (PLT) \<150,000 /mm3
  10. * Previous infiltrative treatment within 3 weeks prior to scheduled treatment
  11. * Pregnancy/Breastfeeding
  12. * Hypersensitivity to HA
  13. * Inability to complete an MRI due to metal implants or claustrophobia
  14. * Diabetes
  15. * Active treatment for a malignancy
  16. * Active wound in the knee
  17. * Recent history of knee trauma
  18. * Vasovagal history
  19. * An injection of hyaluronic acid (HA) or platelet-rich plasma (PRP) to the affected knee within the last two years.
  20. * In the judgment of the investigator, the patient is unable to perform and/or complete all of the study visits or treatments required.

Contacts and Locations

Study Contact

Jason L Koh, MD, MBA
CONTACT
224-251-3481
jkoh@northshore.org
Sarah L Rabbitt, RN, BSN
CONTACT
847-933-6345
srabbitt@northshore.org

Principal Investigator

Jason L Koh, MD, MBA
PRINCIPAL_INVESTIGATOR
Clinical Chairman, Dept. of Orthopaedics

Study Locations (Sites)

NorthShore University HealthSystems
Skokie, Illinois, 60076
United States

Collaborators and Investigators

Sponsor: NorthShore University HealthSystem

  • Jason L Koh, MD, MBA, PRINCIPAL_INVESTIGATOR, Clinical Chairman, Dept. of Orthopaedics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-06-13
Study Completion Date2027-12

Study Record Updates

Study Start Date2018-06-13
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Knee Osteoarthritis