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ArtiBest for Knee Osteoarthritis

NCT06994546 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-29

No results posted yet for this study

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.

Conditions

  • Knee Osteoarthristis

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.

Sponsors & Collaborators

  • Maxigen Biotech Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-11
Primary Completion
2025-11-30
Completion
2026-04-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06994546 on ClinicalTrials.gov