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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 28, 2024 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Jun 2020 to Dec 2025
    • Study completion date: Oct 2020 to Dec 2027
    • Eligibility criteria expanded, about 9 words
    v4
  2. Primary completion date: Jun 2019 to Jun 2020v3 Show 4 more changesShow less
    • Study completion date: Oct 2019 to Oct 2020
    • Secondary endpoint revised
    • Study description expanded, about 8 words
    • Eligibility criteria expanded, about 2 words
  3. Primary completion date: Jun 21, 2018 to Jun 2019v2 Show 5 more changesShow less
    • Start date: Apr 21, 2017 to Jun 13, 2018
    • Study completion date: Apr 21, 2019 to Oct 2019
    • Eligibility criteria expanded, about 41 words
    • Secondary endpoint revised
    • Study description revised
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03491761
Lead Sponsor Endeavor Health
Conditions
(from sponsor)		 Knee Osteoarthritis
Related terms Osteoarthritis, Knee
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov