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

Maxigen Biotech Inc.59 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hyaluronic Acid

Interventions

ArtiAid® Plus Intra-articular InjectionDEVICE

Inject ArtiAid® Plus in the affected joint at weekly interval for 3 weeks

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Maxigen Biotech Inc.

Taoyuan City, Taiwan (r.o.c.), Taiwan

Outcomes

Primary Outcomes

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.

Time frame: 0 week to 26 weeks after injections

Secondary Outcomes

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.

Time frame: 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.

Time frame: 4 weeks, and 26 weeks after injections

Data from ClinicalTrials.gov

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