Clinical trial NCT05881317: ArtiAid® Plus for Knee Osteoarthritis: A Post-market Study
Official title: Intra-Articular Hyaluronic Acid (ArtiAid® Plus) for Knee Osteoarthritis: A Post-market, Open-Label, Long-Term Historical Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyaluronic Acid
Keywords: Viscosupplements
Osteoarthritis, Knee
Injections, Intra-Articular
Lead sponsor: Maxigen Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-31
Enrollment: 59
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this open-label, post-market clinical follow-up study is to demonstrate the safety and performance of ArtiAid® Plus Intra-articular Injection in patients with knee osteoarthritis(OA). The main questions it aims to answer are:

* the safety profile of ArtiAid® Plus;
* the clinical performance of ArtiAid® Plus, such as pain relief and satisfaction of treatment.

Participants will receive weekly injections of ArtiAid® Plus for 3 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 3 injections of ArtiAid® Plus 1.5% (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® Plus. The secondary endpoints of this study are demonstrating the clinical performance of ArtiAid® Plus, 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.

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.

Primary outcomes:
measure: Incidence of Treatment-related Adverse Events
timeFrame: 0 week to 26 weeks after injections
Secondary outcomes:
measure: Resting knee pain: VAS (visual analog scale)
timeFrame: Baseline, 4 weeks, and 26 weeks after injections
measure: Satisfaction of treatment: VAS (visual analog scale)
timeFrame: 4 weeks, and 26 weeks after injections
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Maxigen Biotech Inc.
state: Taiwan (r.o.c.)
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Cheng Fong Chen
role: PRINCIPAL_INVESTIGATOR
References: