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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis

Study acronym: DR-HAKOA
StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 14, 2026 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Trial status changed: Not Yet Recruiting → Active, Not Recruitingv2 Show 4 more changesShow less
    • Primary completion pushed from Jun 1, 2026 to Aug 1, 2026
    • Study completion pushed from Aug 1, 2026 to Sep 1, 2026
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 1, 2026 to Jan 15, 2026
  2. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to directly compare two hyaluronic acid injection protocols in adults with knee osteoarthritis: a single intra-articular injection of Innoryos 2.5% (Single-Shot) and a three-week injection series of Innoryos 2.2% (Triple-Shot). The study aims to determine whether the single injection provides comparable safety, pain relief, and improvement in knee function to the triple-injection protocol. The main questions are: * How do the single-shot and triple-shot protocols compare in terms of pain reduction and functional improvement? * How do their safety and tolerability profiles compare? * What medical problems occur with each protocol? Participants (n = 46) will receive either the single 4.8 ml injection or three weekly 2 ml injections. They will attend clinic visits at baseline, Week 6, Week 12, and Week 24 for assessments including WOMAC score, 7-day pain diary, functional and strength tests, and MRI scans of the knee. This single-center, partially blinded, randomized study will provide a direct comparison of the two HA injection protocols, assessing whether the single-shot approach is as safe and effective as the triple-shot regimen, while potentially offering a more convenient, patient-friendly treatment.
Trial Details
NCT Number NCT07352540
Lead Sponsor University of Erlangen-Nürnberg Medical School
Collaborators: Friedrich-Alexander-Universität Erlangen-Nürnberg
Conditions
(from sponsor)
Osteoarthritis, Knee
Related terms Osteoarthritis, Osteoarthritis, Knee
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov