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OpenTrials
Completed

NCT Number: NCT05881330

ArtiAid® for Knee Osteoarthritis: A Post-market 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.

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Key information

Conditions

Hyaluronic Acid Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tri-Service General Hospital

Taoyuan City, Taiwan (r.o.c.), 33383, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ArtiAid Intra-articular Injection

Device

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

Primary outcomes

  1. Incidence of Treatment-related Adverse Events

    Time frame: 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 outcomes

  1. Resting knee pain: VAS (visual analog scale)

    Time frame: 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.

  2. Satisfaction of treatment: VAS (visual analog scale)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Maxigen Biotech Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 31, 2023
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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