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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hyaluronic Acid

Intervention / Treatment
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* Device: ArtiAid® Plus Intra-articular Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ArtiAid® Plus group<br>Each pre-filled syringe contains 15 mg/ml (1.5%) sodium hyaluronate, subjects received one injection per week for three weeks. | Device: ArtiAid® Plus Intra-articular Injection<br>* Inject ArtiAid® Plus in the affected joint at weekly interval for 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-related Adverse Events | 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. | 0 week to 26 weeks after injections | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting knee pain: VAS (visual analog scale) | 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. | Baseline, 4 weeks, and 26 weeks after injections | 
| Satisfaction of treatment: VAS (visual analog scale) | 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. | 4 weeks, and 26 weeks after injections | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Viscosupplements, Osteoarthritis, Knee, Injections, Intra-Articular