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Actively Recruiting

Phase Not Applicable
Age: 35Years - 85Years
All Genders
ID06994546

Study of ArtiBest Injection for Treatment of Knee Osteoarthritis in Adults Aged 35 to 85

Led by Maxigen Biotech Inc. · Updated on 2025-05-29

60

Participants Needed

1

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the real-world effectiveness and safety of ArtiBest, a sodium hyaluronate injection, for treating knee osteoarthritis. The study focuses on changes in pain, patient global assessments, satisfaction, and responder rates up to 26 weeks after treatment. Approximately 60 patients with mild to moderate knee osteoarthritis who have not responded well to other therapies will be enrolled. Participants will receive a single 3 ml intra-articular injection of ArtiBest per knee joint containing 20 mgmL sodium hyaluronate. Follow-up includes a phone contact at 4 weeks and in-person visits at 12 and 26 weeks post-injection. The study will analyze pain scores, range of motion, joint space, and osteoarthritis severity over the treatment period. During the study, participants will undergo evaluations at baseline and follow-up visits including pain assessments using WOMAC and VAS scores, Patients Global Assessment, responder rates, and satisfaction scores. Safety will be monitored through reported adverse events. Statistical analysis will compare changes from baseline to 12 and 26 weeks. The total participation period includes screening, treatment, and follow-up over about six months.

CONDITIONS

Brief Title

ArtiBest for Knee Osteoarthritis

Research Team

C

Chen

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