J ISAKOS. 2025 Feb;10:100363. doi: 10.1016/j.jisako.2024.100363. Epub 2024 Nov 14.
Joint-preserving interventions, such as intra-articular viscosupplementation injections, are evolving and requiring efficacy and safety evaluations through an evidence-based approach. The objective of this study was to assess the use of a hyaluronic acid and corticosteroid-based injection (Cingal™; Anika Therapeutics, Bedford, MA, USA) in improving pain and functional outcomes for patients aged between 40 and 65 with mild to moderate hip osteoarthritis (OA) six months post-injection.
This prospective observational study included 100 patients receiving a single ultrasound-guided intra-articular injection of Cingal™. Eligible patients seen in participating orthopaedic, physiatry and sports medicine clinics were evaluated at baseline, one-month, and six-month follow-up. The primary outcome was patient-reported hip pain (Visual Analogue Scale, VAS) at six months post-injection. Secondary outcomes included hip function (Hip Disability and Osteoarthritis Outcome Score, HOOS), quality of life (Short-Form 12, SF-12), pain medication use, range of motion (ROM), physical activity (activity tracker), and adverse events.
Ninety-six patients received the injection; 91 had complete data for primary outcome analysis. Statistically significant improvements were observed in VAS (p < 0.001), HOOS (p < 0.001), and SF-12 scores (Physical Component Summary, p = 0.005; Mental Component Summary, p = 0.022) from baseline to six months post-injection. Pain medication use decreased from 50.0% to 34.0% (p = 0.035). No statistically significant change was observed in ROM or activity level. Adverse events were reported in 9.5% of patients: five (5.3%) experienced hip pain for less than seven days, one for more than seven days but less than one month, and three (3.2%) underwent hip arthroplasty.
Patients receiving an ultrasound-guided Cingal™ injection for hip OA reported statistically significantly reduced hip pain, improved function and quality of life, and reduced pain medication use at six months. The most common adverse event was transient hip pain.
Prospective observational study, Level III.
诸如关节内注射补充粘弹性物质等保关节干预措施正在不断发展,需要通过循证方法对其疗效和安全性进行评估。本研究的目的是评估一种基于透明质酸和皮质类固醇的注射剂(Cingal™;美国马萨诸塞州贝德福德市的阿妮卡治疗公司)对40至65岁轻度至中度髋骨关节炎(OA)患者注射后6个月时疼痛和功能结局的改善情况。
这项前瞻性观察性研究纳入了100例接受单次超声引导下关节内注射Cingal™的患者。在参与研究的骨科、物理医学与康复科以及运动医学诊所就诊的符合条件的患者在基线、1个月和6个月随访时接受评估。主要结局是患者报告的注射后6个月时的髋部疼痛(视觉模拟量表,VAS)。次要结局包括髋关节功能(髋关节残疾和骨关节炎结局评分,HOOS)、生活质量(简明健康调查简表,SF - 12)、止痛药物使用情况、活动范围(ROM)、身体活动(活动追踪器)以及不良事件。
96例患者接受了注射;91例有完整数据用于主要结局分析。从基线到注射后6个月,观察到VAS(p < 0.001)、HOOS(p < 0.001)和SF - 12评分(身体成分总结,p = 0.005;心理成分总结,p = 0.022)有统计学显著改善。止痛药物使用从50.0%降至34.0%(p = 0.035)。ROM或活动水平未观察到统计学显著变化。9.5%的患者报告了不良事件:5例(5.3%)经历了不到7天的髋部疼痛,1例超过7天但不到1个月,3例(3.2%)接受了髋关节置换术。
接受超声引导下Cingal™注射治疗髋OA的患者在6个月时报告髋部疼痛在统计学上显著减轻、功能和生活质量改善以及止痛药物使用减少。最常见的不良事件是短暂性髋部疼痛。
前瞻性观察性研究,III级。