Real-world Efficacy and Safety of Sinovial®HL Single Injection in the Treatment of Symptomatic Knee Osteoarthritis: an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Visual Analog Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Fifty consecutive patients who met the inclusion criteria participated in the study
Consecutive patients with knee osteoarthritis and with a medical indication for viscosupplementation with hybrid hialuronic acid (HA) who fulfilled the inclusion criteria were recruited for the study. The inclusion criteria were: a medical indication for viscosupplementation therapy with hybrid HA; patients aged between 45 and 80 years; diagnosis of femorotibial gonarthrosis associated with femoro-patellar arthrosis or isolated, gonarthrosis symptoms for at least 6 months; patients who failed to respond to analgesics and/or regular NSAIDs, or were proved to be intolerant to the regular use of analgesics, NSAIDS, or weak opioids; grade 2 to 3 OA in the Kellgren-Lawrence grading scale ; pain when walking measured by the Visual Analog Scale of at least 40 mm on the targeted knee; and contralateral knee pain when walking with aVAS of less than 10 mm. The exclusion criteria were: inability to understand the aim of the study, inability to provide acceptable consent, pregnancy, serious ps
干预措施: Sinovial (Drug)
结局指标
主要结局
Visual Analog Scale
时间窗: 6 month
Visual Analog Scale for the assessment of the pain during the study. Scale 0 ( no pain ) to 10 ( extreme pain )
The Western Ontario and McMaster Universities Arthritis Index
时间窗: 6 months
The Western Ontario and McMaster Universities Arthritis Index ( WOMAC ) is used to assess the function of the knee in osteoarthritis. Scale 0 ( the worst result ) -100 ( the best result )
次要结局
未报告次要终点
研究者
Marcin Domżalski
Principal Investigator
Sporto Clinic