Hyaluronic Acid
Conditions
Keywords
Viscosupplements, Osteoarthritis, Knee, Injections, Intra-Articular
Brief 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.
Interventions
DEVICEArtiAid® Plus Intra-articular Injection
Inject ArtiAid® Plus in the affected joint at weekly interval for 3 weeks
Sponsors
Maxigen Biotech Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Taiwan
Outcome results
None listed