Comparing Efficacy and Safety of a Single Intraarticular Injection of a Novel Crosslinked Hyaluronic Acid (HYAJOINT Plus) With Synvisc-One for the Treatment of Knee Osteoarthritis: A Randomized-Controlled, Double-Blind Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- VAS pain score
研究概览
简要总结
Viscosupplementation has been widely used for the treatment of knee osteoarthritis (OA). There is no well controlled trial comparing one injection regimen of HA for the treatment of knee OA. The purpose of this study was to compare the efficacy and safety of one intraarticular injection of a novel crosslinked HA (HYAJOINT Plus) with Synvisc-One for the treatment of knee OA.
详细描述
In a prospective, randomized controlled, double-blind trial with 6-month follow up, patients with knee OA (Kellgren-Lawrence grade 2 or 3) were randomized to receive one intraarticular injection of 3 ml HYAJOINT Plus (microbial fermented HA, 20 mg/ml) (N=66) or 6 ml Synvisc-One (avian derived HA, 8 mg/ml) (N=66). The primary outcome was change in the visual analog scale (VAS) pain (0-100mm) over 6 months. Secondary outcomes included The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne index, Timed Up-and-Go test (TUG), single leg stance test (SLS), use of rescue analgesics and patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic knee OA with pain for at least 6 months, despite conservative treatment such as analgesics, NSAIDs and/or physical therapy
- •average pain on knee movement of 30 mm or greater on a 100-mm VAS
- •grade 2 or 3 knee OA according to the Kellgren-Lawrence grading system based on radiographs taken within the previous 6 months
- •Radiological evidence of bilateral knee OA was accepted if global pain VAS in the contralateral knee was less than 30 mm.
排除标准
- •previous orthopedic surgery on the spine or lower limbs
- •disabling OA of either hip or foot
- •knee instability, clinical apparent joint effusion or marked valgus/varus deformity
- •known allergy to avian proteins or HA products
- •women ascertained or suspected pregnancy or lactating
- •intraarticular injections within the past 6 months
- •infections or skin diseases around the target knee
- •any specific medical conditions (rheumatoid arthritis, hemiparesis, neoplasm, etc.) that would interfere with the assessments
结局指标
主要结局
VAS pain score
时间窗: at 1, 3 and 6 months postinjection
the change from baseline in the VAS pain score over 6 months.
次要结局
- WOMAC, Likert Scale(at 1, 3 and 6 months postinjection)
- Lequesne index(at 1, 3 and 6 months postinjection)
- Timed Up-and-Go test (TUG)(at 1, 3 and 6 months postinjection)
- Single-leg stance test (SLS)(at 1, 3 and 6 months postinjection)
- satisfaction based on a 100 mm VAS(at 1, 3 and 6 months postinjection)
- The reported adverse events(at 1 week (safety records via phone call), 1, 3 and 6 months after the injection)
研究者
Shu-Fen Sun
MD
Kaohsiung Veterans General Hospital.