ArtiAid® for Knee Osteoarthritis: A Post-market Study

NCT ID: NCT05881330

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-11-25

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.

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.

Conditions

Hyaluronic Acid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

ArtiAid® group

Each pre-filled syringe contains 10 mg/ml (1.0%) sodium hyaluronate, subjects received one injection per week for five weeks.

Group Type: EXPERIMENTAL

ArtiAid Intra-articular Injection

Intervention Type: DEVICE

Inject ArtiAid® in the affected joint at weekly interval for 5 weeks.

Interventions

ArtiAid Intra-articular Injection

Inject ArtiAid® in the affected joint at weekly interval for 5 weeks.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maxigen Biotech Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tsu-Te Yeh, Doctor

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital

Locations

Tri-Service General Hospital

Taoyuan, Taiwan (r.o.c.), Taiwan

Countries

Taiwan

Other Identifiers

MCQ-AA2105

Identifier Type: -

Identifier Source: org_study_id