Intra-Articular Hyaluronic Acid (ArtiAid® Plus) for Knee Osteoarthritis: A Post-market, Open-Label, Long-Term Historical Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-related Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of Treatment-related Adverse Events
时间窗: 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.
次要结局
- Resting knee pain: VAS (visual analog scale)(Baseline, 4 weeks, and 26 weeks after injections)
- Satisfaction of treatment: VAS (visual analog scale)(4 weeks, and 26 weeks after injections)