Actively Recruiting
Intra Articular Hyaluronic Acid (ArtiBest 4) for Knee Osteoarthritis: A Post-market, Open Label, Long Term Study
Led by Maxigen Biotech Inc. · Updated on 2025-05-29
60
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
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 mg/mL 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, Patient's 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 35 to 85 years
- X-ray evidence of knee osteoarthritis with Kellgren Lawrence grade 2 or 3 within 1 month before screening
- Diagnosis of mild to moderate knee osteoarthritis
- Resting knee pain score of at least 30 mm on a 100 mm scale at screening and treatment visits
- Able and willing to comply with all study visits and procedures
- Capable of providing written informed consent
You will not qualify if you...
- Known allergy or hypersensitivity to hyaluronate
- Infection or skin disease at the injection site
- Pregnant or breastfeeding women
- Participation in another interventional trial within 3 months before injection
- Received hyaluronic acid or steroid injection in the target knee within 6 months before the trial
- Rheumatoid arthritis diagnosis
- Surgery on the target knee within 12 months before the trial
- Surgery on the opposite knee or other weight-bearing joint that may affect knee assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single intra articular injection of ArtiBest (3 ml per knee joint).
1 treatment visit (in-person)
Duration - 26 weeks
Participants are monitored through follow-up visits to assess effectiveness and safety after the injection.
1 telephone visit at 4 weeks and 2 in-person visits at 12 and 26 weeks post-injection
Trial Site Locations
Total: 1 location
1
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
Research Team
C
Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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