NCT05881317

ArtiAid® Plus for Knee Osteoarthritis: A Post-market Study

Intra-Articular Hyaluronic Acid (ArtiAid® Plus) for Knee Osteoarthritis: A Post-market, Open-Label, Long-Term Historical Control Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Maxigen Biotech Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The goal of this open-label, post-market clinical follow-up study is to demonstrate the safety and performance of ArtiAid® Plus Intra-articular Injection in patients with knee osteoarthritis(OA). The main questions it aims to answer are: * the safety profile of ArtiAid® Plus; * the clinical performance of ArtiAid® Plus, such as pain relief and satisfaction of treatment. Participants will receive weekly injections of ArtiAid® Plus for 3 weeks and be follow-up for 26 weeks.

Detailed description

An open-label study will be performed in single center to monitor about 60 patients with knee osteoarthritis(OA), each treated with 3 injections of ArtiAid® Plus 1.5% (MAXIGEN BIOTECH INC., Taiwan). Follow-up visits will be at 4 weeks, 12 weeks(a telephone contact by the investigator) and 26 weeks after the injections. The primary endpoint of this study is to monitor the adverse events after injecting ArtiAid® Plus. The secondary endpoints of this study are demonstrating the clinical performance of ArtiAid® Plus, such as resting knee pain and satisfaction of treatment by using the visual analog scale (VAS). Analysis of variance (ANOVA) will be applied to the clinical data and T-test will be used to test for the differences between baseline and each visit. The paired student t-test was used to analyze variations in each group over a period of time. Statistical significance was established at p \< 0.05.

Conditions

• Hyaluronic Acid

Interventions

Type	Name	Description
DEVICE	ArtiAid® Plus Intra-articular Injection	Inject ArtiAid® Plus in the affected joint at weekly interval for 3 weeks

Timeline

• Start date: 2021-08-02
• Primary completion: 2022-06-06
• Completion: 2022-11-21
• First posted: 2023-05-31
• Last updated: 2023-05-31

Locations

1 site across 1 country: Taiwan