Intra Articular Hyaluronic Acid (ArtiBest ® ) for Knee Osteoarthritis: A Post-market, Open Label, Long Term Study
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.
• Age from 35 to 85 years.
• Subject with x ray imaging evidence of knee OA as Kellgren Lawrence grade = 2 or 3 within 1 month at screening.
• Subject diagnosed with mild to moderate knee OA, particularly in patients who failed to respond adequately to conservative nonpharmacologic therapies or analgesics.
• Subject with a 100 mm VAS resting pain score ≥ 30 mm in the studied knee at both the screening and treatment visit (screening visit and treatment visit can be on the same day)
• Able and willing to comply with all study visits and procedures.
• Willin g and capable of providing written informed consent.