Evaluating ArtiBest for treating knee osteoarthritis
Intra Articular Hyaluronic Acid (ArtiBest ® ) for Knee Osteoarthritis: A Post-market, Open Label, Long Term Study
This study is testing if a new knee injection called ArtiBest can help people aged 35 to 85 with knee osteoarthritis feel less pain and move better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 35 Years to 85 Years |
| Sex | All |
| Sponsor | Maxigen Biotech Inc. Industry-sponsored |
| Locations | 1 site (Kaohsiung City) |
| Trial ID | NCT06994546 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness and safety of ArtiBest, an intra-articular injection containing sodium hyaluronate, for patients with knee osteoarthritis. Participants aged 35 to 85 with mild to moderate knee OA will receive a single injection and will be followed up at 4, 12, and 26 weeks to evaluate changes in pain scores and overall joint function. The study will measure various outcomes, including pain relief and patient satisfaction, using established scoring systems. Statistical analyses will be performed to determine the significance of the results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 35 to 85 with mild to moderate knee osteoarthritis who have not adequately responded to conservative treatments.
Not a fit: Patients with severe knee osteoarthritis, infections at the injection site, or known hypersensitivity to hyaluronate may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief and improved joint function for patients suffering from knee osteoarthritis.
How similar studies have performed: Previous studies have shown positive outcomes with similar hyaluronic acid injections for knee osteoarthritis, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Subjects with known hypersensitivity to hyaluronate. * Subjects with infections or skin diseases in the area of the injection site. * Pregnancy or breast feeding woman. * Joining other interventional trial s within 3 months prior to injecting this study product * Subject receive an intra articular (IA) injection of Hyaluronic Acid (HA) and/or steroid in target knee within 6 months prior to the trial * Subjects with rheumatoid arthritis * Any surgery to the target knee within the 12 months prior to the trial, or surgery to the contralateral knee or other weight bearing joint if it will interfere with knee assessments
Where this trial is running
Kaohsiung City
- Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan (Recruiting)
Study contacts
- Study coordinator: Chen
- Email: lirong.chen@mbi.com.tw
- Phone: +88633287222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.