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ArtiBest for Knee Osteoarthritis
Sponsor: Maxigen Biotech Inc.
Summary
The goal of this clinical trial is to evaluate the real-world effectiveness and safety of ArtiBest in the treatment of knee osteoarthritis. The main questions it aims to answer are: 1. The change from baseline The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at 26 weeks post injection. 2. The change from baseline VAS resting pain score at 12 and 26 weeks post injection. 3. The change from baseline The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at 12 weeks post injection. 4. The change from baseline Patient's Global Assessment PGA) using VAS scoring at 12 and 26 weeks post injection. 5. The OMERACT OARSI responder rate at 12 and 26 weeks post injection. 6. The VAS satisfaction score at 12 and 26 weeks post injection 7. The incidence of Adverse events reported during the study period. Participants will undergo a single injection of ArtiBest at treatment visit, and three follow up visits at week 4 , 12 , and 26.
Official title: Intra Articular Hyaluronic Acid (ArtiBest ® ) for Knee Osteoarthritis: A Post-market, Open Label, Long Term Study
Key Details
Gender
All
Age Range
35 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-03-11
Completion Date
2026-04-30
Last Updated
2025-05-29
Healthy Volunteers
No
Conditions
Interventions
ArtiBest ® Intra articular Injection
single intra articular injection of 3 ml (one syringe) per knee joint. Each syringe contains 20 mg/mL sodium hyaluronate.
Locations (1)
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan