Department of Orthopedics, E-da Hospital, I-Shou University, 84001 Kaohsiung, Taiwan.
Jt Dis Relat Surg. 2023;34(1):50-57. doi: 10.52312/jdrs.2023.876. Epub 2023 Jan 6.
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.
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.
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.
The intra-articular injection of either AAM or OM is effective and safe for patients with trapeziometacarpal osteoarthritis up to 24 weeks.
本研究旨在比较 ArtiAid®-Mini（AAM）和 Ostenil®-Mini（OM）关节内注射治疗腕掌关节骨关节炎的疗效和安全性。
2018 年 2 月至 2020 年 4 月，这项 24 周、双盲、前瞻性、随机、非劣效性试验纳入了 17 名患者（8 名男性，9 名女性；平均年龄：60.3±9.5 岁；年龄范围 42 至 76 岁），他们分别接受了关节内 AAM（n=8）或 OM（n=9）治疗。主要结局是末次注射后 12 周时根据视觉模拟量表（VAS）变化评估的疼痛。次要结局包括注射后 2、4 和 24 周时 VAS 的变化、满意度、腕掌关节活动度（ROM）、捏力、握力以及注射后 2、4、12 和 24 周时的不良事件。
8 名 AAM 患者和 8 名 OM 患者完成了随访。两组在基线和每个时间点的主要和次要结局均无显著差异（p>0.05）。每组在每个时间点的组内差异均有统计学意义。
关节内注射 AAM 或 OM 治疗腕掌骨关节炎在 24 周内均有效且安全。
