ArtiAid® for Knee Osteoarthritis: A Post-market Study

Intra-Articular Hyaluronic Acid(ArtiAid® ) 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® Intra-articular Injection in patients with knee osteoarthritis(OA). The main questions it aims to answer are:

• the safety profile of ArtiAid®;
• the clinical performance of ArtiAid®, such as pain relief and satisfaction of treatment.

Participants will receive weekly injections of ArtiAid® for 5 weeks and be follow-up for 26 weeks.

Study Overview

• Status: Completed
• Conditions: Hyaluronic Acid
• Intervention / Treatment: Device: ArtiAid Intra-articular Injection

Detailed Description

An open-label study will be performed in single center to monitor about 60 patients with knee osteoarthritis(OA), each treated with 5 injections of ArtiAid® 1.0% (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®. The secondary endpoints of this study are demonstrating the clinical performance of ArtiAid®, 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
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taiwan (r.o.c.)
    • Taoyuan City, Taiwan (r.o.c.), Taiwan, 33383
      • Tri-Service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ArtiAid® group; Each pre-filled syringe contains 10 mg/ml (1.0%) sodium hyaluronate, subjects received one injection per week for five weeks.	Device: ArtiAid Intra-articular Injection; Inject ArtiAid® in the affected joint at weekly interval for 5 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0 week to 26 weeks after injections

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	4 weeks, and 26 weeks after injections

Collaborators and Investigators

• Sponsor: Maxigen Biotech Inc.
• Investigators: Principal Investigator: Tsu-Te Yeh, Doctor, Tri-Service General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): September 22, 2022
• Study Completion (Actual): November 25, 2022

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Osteoarthritis, Knee; Injections, Intra-Articular; Viscosupplements
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: MCQ-AA2105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No