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RECRUITING
NCT06994546
NA

ArtiBest for Knee Osteoarthritis

Sponsor: Maxigen Biotech Inc.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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