Original Article · Open access
Comparison of intra-articular injection of ArtiAid®-Mini with Ostenil®-Mini for trapeziometacarpal osteoarthritis: A double-blind, prospective, randomized, non-inferiority trial
Abstract
Objectives: This study aims to compare the effectiveness and safety of intra-articular hyaluronic acid (HA) injections of ArtiAid®-Mini (AAM) and Ostenil®-Mini (OM) for the treatment of trapeziometacarpal joint osteoarthritis.
Patients and methods: Between February 2018 and April 2020, this 24-week, double-blind, prospective, randomized, non-inferiority trial included a total of 17 patients (8 males, 9 females; mean age: 60.3±9.5 years; range, 42 to 76 years) who were treated with either intra-articular AAM (n=8) or OM (n=9). The primary outcome was pain according to a change in Visual Analog Scale (VAS) at 12 weeks after the last injection. The secondary outcomes included the change of VAS at Weeks 2, 4, and 24 after the injection, satisfaction, range of motion (ROM) of trapeziometacarpal joint, pinch strength, grip strength, and adverse events at Weeks 2, 4, 12, and 24 after the injection.
Results: Eight patients with AAM and eight patients with OM completed the follow-up. No significant differences in primary and secondary outcomes were observed between the two groups at baseline and each time point (p>0.05). The intra-group differences were significant in each time point.
Conclusion: The intra-articular injection of either AAM or OM is effective and safe for patients with trapeziometacarpal osteoarthritis up to 24 weeks.
Declarations
Ethics Committee Approval
The study protocol was approved by the Institutional Review Board of the E-Da Hospital Ethics Committee (date: 07.12.2017, no: EMRP03106N). The study was conducted in accordance with the principles of the Declaration of Helsinki.
Informed Consent
A written informed consent was obtained from each patient.
Data Sharing Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.
Author Contributions
Manuscript drafting, Analysis of data: P.H.W.; Acquisition of data: C.H.W.; Acquisition of data: C.H.M.; Analysis of data: Y.C.C.; Full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis, study design: P.T.W., I.M.J. All authors reviewed and edited the manuscript and approved the final version of the manuscript.
Conflict of Interest
One authors (I.M.Jou) received funding from Maxigen Biotech Inc., for the planning and execution of this study. Maxigen Biotech Inc., had no role in this study, including patient enrollment, data collection, data analysis, interpretation of the study findings, and manuscript preparation.
Financial Disclosure
This trial was sponsored by Maxigen Biotech Inc., the manufacturer of ArtiAid®-Mini.