ArtiAid® for Knee Osteoarthritis: A Post-market Study

Not Applicable

Completed

• Conditions: Hyaluronic Acid
• Interventions: Device: ArtiAid Intra-articular Injection

• Registration Number: NCT05881330
• Lead Sponsor: Maxigen Biotech Inc.

Brief Summary

The goal of this open-label, post-market clinical follow-up study is to demonstrate the safety and performance of ArtiAid® Intra-articular Injection in patients with knee osteoarthritis(OA). The main questions it aims to answer are:

* the safety profile of ArtiAid®;

* the clinical performance of ArtiAid®, such as pain relief and satisfaction of treatment.

Participants will receive weekly injections of ArtiAid® for 5 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 5 injections of ArtiAid® 1.0% (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®. The secondary endpoints of this study are demonstrating the clinical performance of ArtiAid®, 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.

Study Timeline

• Study Start: 2021-07-01
• Primary Completion: 2022-09-22
• Study Completion: 2022-11-25
• Status Verified: 2023-05
• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-19
• Last Update Submitted: 2023-05-19
• Study First Posted: 2023-05-31
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Subjects aged older than 40 years old.
• Able to sign informed consent prior to the study.
• Subjects have Kellgren-Lawrence (KL) grade 2 to 3 knee osteoarthritis.
• Subjects have failed to respond adequately to conservative non-pharmacological therapy.
• Plasma pregnancy test at screening visit must be negative for fertile female subjects.
• Subjects in stable progress of disease as judged by the investigator.

Exclusion Criteria

• Subjects with known hypersensitivity to hyaluronate preparations.
• Subjects with infections or skin diseases in the area of the injection site.
• Pregnancy or breast-feeding woman.
• Significant drug, alcohol abuse.
• Joining any clinical trial within 3 months prior to dosing.
• Subjects have traveled abroad within 3 months prior to the screening visit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ArtiAid® group	ArtiAid Intra-articular Injection	Each pre-filled syringe contains 10 mg/ml (1.0%) sodium hyaluronate, subjects received one injection per week for five weeks.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-related Adverse Events	0 week to 26 weeks after injections	The adverse events are defined as any unfavorable sign occurrence in a subject after treatment. The investigator assesses the severity and the relationship of each event to the use of the study device.

Secondary Outcome Measures

Name	Time	Method
Satisfaction of treatment: VAS (visual analog scale)	4 weeks, and 26 weeks after injections	The satisfaction of treatment will be assessed by a patient-reported VAS (visual analog scale), subjects mark on a 0-100 mm line, where 0 represent "least satisfied" and 100 represents "highest satisfaction". The VAS pain score will be assessed at 4 weeks and 26 weeks after injections.
Resting knee pain: VAS (visual analog scale)	Baseline, 4 weeks, and 26 weeks after injections	Current level of resting knee pain will be assessed by a patient-reported VAS (visual analog scale), subjects mark on a 0-100 mm line, where 0 represent "no pain" and 100 represents "maximum pain". The VAS pain score will be assessed at baseline 4 weeks and 26 weeks after injections.

Trial Locations

Locations (1)

Tri-Service General Hospital; 🇨🇳 Taoyuan City, Taiwan (r.o.c.), Taiwan