ArtiAid® Plus for Knee Osteoarthritis: A Post-market Study
- Conditions
- Hyaluronic Acid
- Interventions
- Device: ArtiAid® Plus Intra-articular Injection
- Registration Number
- NCT05881317
- Lead Sponsor
- Maxigen Biotech Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ArtiAid® Plus group ArtiAid® Plus Intra-articular Injection Each pre-filled syringe contains 15 mg/ml (1.5%) sodium hyaluronate, subjects received one injection per week for three weeks.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Maxigen Biotech Inc.
🇨🇳Taoyuan City, Taiwan (r.o.c.), Taiwan