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

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.

Each pre-filled syringe contains 15 mg/ml (1.5%) sodium hyaluronate, subjects received one injection per week for three weeks.

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.

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.

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.

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.