ArtiAid® for Knee Osteoarthritis: A Post-market Study

Sponsor

Maxigen Biotech Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT05881330

Collaborator

(none)

Enrollment

Location

Arm

16.8

Actual Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hyaluronic Acid	Device: ArtiAid Intra-articular Injection	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Intra-Articular Hyaluronic Acid(ArtiAid® ) for Knee Osteoarthritis: A Post-market, Open-Label, Long-Term Historical Control Study

Actual Study Start Date :

Jul 1, 2021

Actual Primary Completion Date :

Sep 22, 2022

Actual Study Completion Date :

Nov 25, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tri-Service General Hospital	Taoyuan City	Taiwan (r.o.c.)	Taiwan	33383

Sponsors and Collaborators

Maxigen Biotech Inc.

Investigators

Principal Investigator: Tsu-Te Yeh, Doctor, Tri-Service General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maxigen Biotech Inc.

ClinicalTrials.gov Identifier:

NCT05881330

Other Study ID Numbers:

MCQ-AA2105

First Posted:

May 31, 2023

Last Update Posted:

May 31, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Maxigen Biotech Inc.

Viscosupplements

Osteoarthritis, Knee

Injections, Intra-Articular

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of May 31, 2023