Domzalski Marcin E, Marchewa Klaudia
Department of Orthopedic and Trauma, Medical University of Lodz, Zeromskiego Str. 113, 90-549, Lodz, Poland.
SPORTO Clinic, Miedziana Str 13/15, 90-038, Lodz, Poland.
Rheumatol Ther. 2025 Jul 2. doi: 10.1007/s40744-025-00780-8.
The prevalence of knee osteoarthritis (OA) is rising worldwide, leading to disability and a reduced quality of life, particularly in elderly patients. While there are several treatment options, there is little consensus in the scientific community over which methods are most effective. Viscosupplementation with hyaluronic acid (HA) has been found to reduce pain in patients with knee OA over a period of up to 6 months, with little to no side effects. The aim of this prospective open-label, uncontrolled, observational, single-site study was to assess the efficacy and safety of a single hybrid HA injection over a period of 6 months in subpopulations of patients with low to severe symptomatic knee OA in everyday clinical practice.
Fifty patients who met the inclusion criteria participated in the study. A single intra-articular ultrasound-guided injection of hybrid HA (Sinovial®) was administered. Patients submitted Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaires at 28, 42, 84, and 168 days post-treatment.
VAS scores measured at rest and when walking indicate an improvement during follow-up, particularly at 28 and 42 days, compared to baseline. Similarly, the most notable improvement of the WOMAC score was observed within the first 42 days after injection. While decrease in pain and joint function improvement were not as pronounced at the end of follow-up, they were still statistically better than at baseline. Overall patient satisfaction was high.
Treatment with a single injection of hybrid HA was demonstrated to be safe and effective in patients with varying degrees of knee OA. Patients with medial knee OA responded better to treatment than patients with patellofemoral OA, which provides information on which types of patients are best suited to this intervention.
ClinicalTrials.gov identifier, NCT06652893. Retrospectively registered October 10, 2024.
膝关节骨关节炎（OA）在全球的患病率正在上升，导致残疾和生活质量下降，尤其是在老年患者中。虽然有多种治疗选择，但科学界对于哪种方法最有效几乎没有共识。已发现透明质酸（HA）进行关节腔注射补充可在长达6个月的时间内减轻膝关节OA患者的疼痛，且几乎没有副作用。这项前瞻性开放标签、非对照、观察性单中心研究的目的是，在日常临床实践中评估单次混合HA注射在6个月内对轻至重度症状性膝关节OA亚组患者的疗效和安全性。
50名符合纳入标准的患者参与了该研究。进行了单次关节内超声引导下混合HA（Sinovial®）注射。患者在治疗后28、42、84和168天提交视觉模拟量表（VAS）以及西安大略和麦克马斯特大学骨关节炎指数（WOMAC）问卷。
静息和行走时测量的VAS评分显示，与基线相比，随访期间有所改善，尤其是在28天和42天时。同样，WOMAC评分在注射后的前42天内改善最为显著。虽然随访结束时疼痛减轻和关节功能改善不那么明显，但仍在统计学上优于基线。总体患者满意度较高。
单次注射混合HA治疗在不同程度的膝关节OA患者中被证明是安全有效的。膝内侧OA患者对治疗的反应比对髌股关节OA患者更好，这为哪种类型的患者最适合这种干预提供了信息。
ClinicalTrials.gov标识符，NCT06652893。2024年10月10日进行回顾性注册。
