ArtiAid® for Knee Osteoarthritis: A Post-market Study

NCT05881330 | Completed

• 1 other identifier: MCQ-AA2105
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyaluronic Acid

Keywords

Viscosupplements; Osteoarthritis, Knee; Injections, Intra-Articular

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Resting knee pain: VAS (visual analog scale)

  Baseline, 4 weeks, and 26 weeks after injections

• Satisfaction of treatment: VAS (visual analog scale)

  4 weeks, and 26 weeks after injections

Study Arms (1)

ArtiAid® group

EXPERIMENTAL

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

Interventions

ArtiAid Intra-articular Injection DEVICE

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

ArtiAid® group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maxigen Biotech Inc.: lead

Study Sites (1)

Tri-Service General Hospital

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

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Tsu-Te Yeh, Doctor

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 31, 2023
• Study Start: July 1, 2021
• Primary Completion: September 22, 2022
• Study Completion: November 25, 2022
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

TW (1)