Evaluating ArtiBest for treating knee osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Kaohsiung Chang Gung Memorial Hospital
  Kaohsiung City, Taiwan Recruiting

Study contacts

• Study coordinator: Chen
• Email: lirong.chen@mbi.com.tw
• Phone: +88633287222

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.