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ArtiAid® for Knee Osteoarthritis: A Post-market Study

Primary Purpose

Hyaluronic Acid

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
ArtiAid Intra-articular Injection
Sponsored by
Maxigen Biotech Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hyaluronic Acid focused on measuring Viscosupplements, Osteoarthritis, Knee, Injections, Intra-Articular

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Tri-Service General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ArtiAid® group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 19, 2023
Last Updated
May 19, 2023
Sponsor
Maxigen Biotech Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05881330
Brief Title
ArtiAid® for Knee Osteoarthritis: A Post-market Study
Official Title
Intra-Articular Hyaluronic Acid(ArtiAid® ) for Knee Osteoarthritis: A Post-market, Open-Label, Long-Term Historical Control Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
September 22, 2022 (Actual)
Study Completion Date
November 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maxigen Biotech Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyaluronic Acid
Keywords
Viscosupplements, Osteoarthritis, Knee, Injections, Intra-Articular

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ArtiAid® group
Arm Type
Experimental
Arm Description
Each pre-filled syringe contains 10 mg/ml (1.0%) sodium hyaluronate, subjects received one injection per week for five weeks.
Intervention Type
Device
Intervention Name(s)
ArtiAid Intra-articular Injection
Intervention Description
Inject ArtiAid® in the affected joint at weekly interval for 5 weeks.
Primary Outcome Measure Information:
Title
Incidence of Treatment-related Adverse Events
Description
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.
Time Frame
0 week to 26 weeks after injections
Secondary Outcome Measure Information:
Title
Resting knee pain: VAS (visual analog scale)
Description
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.
Time Frame
Baseline, 4 weeks, and 26 weeks after injections
Title
Satisfaction of treatment: VAS (visual analog scale)
Description
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.
Time Frame
4 weeks, and 26 weeks after injections

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsu-Te Yeh, Doctor
Organizational Affiliation
Tri-Service General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tri-Service General Hospital
City
Taoyuan City
State/Province
Taiwan (r.o.c.)
ZIP/Postal Code
33383
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

ArtiAid® for Knee Osteoarthritis: A Post-market Study

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