Comparison of intra-articular injection of ArtiAid®-Mini with Ostenil®-Mini for trapeziometacarpal osteoarthritis: A double-blind, prospective, randomized, non-inferiority trial
Ping-Hui Wang1
, Chin-Hsien Wu2,3, Ching-Hou Ma2,4, Yen-Chun Chiu2, Po-Ting Wu5,6, I-Ming Jou2,7
1Department of Orthopedics, Chi-Mei Medical Center, Tainan, Taiwan
2Department of Orthopedics, E-Da Hospital, Kaohsiung, Taiwan
3School of Medicine, College of Medicine, I-Shou University, Kaohsiung, Taiwan
4School of Medicine for International Students, College of Medicine, I-Shou University, Kaohsiung, Taiwan
5Department of Orthopedics, College of Medicine, National Cheng Kung University, Tainan, Taiwan
6Department of Orthopedics, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan
7GEG Orthopedic Clinic, Tainan, Taiwan
Keywords: ArtiAid®-Mini, hyaluronic acid, Ostenil®-Mini, osteoarthritis, trapeziometacarpal.
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.
Citation: Wang PH, Wu CH, Ma CH, Chiu YC, Wu PT, Jou IM. Comparison of intra-articular injection of ArtiAid®-Mini with Ostenil®-Mini for trapeziometacarpal osteoarthritis: A doubleblind, prospective, randomized, non-inferiority trial. Jt Dis Relat Surg 2023;34(1):50-57. doi: 10.52312/jdrs.2023.876
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.
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.
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.
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.
This trial was sponsored by Maxigen Biotech Inc., the manufacturer of ArtiAid®-Mini.