Early Effect of Cingal® Compared to Monovisc® in Patients With Osteoarthritis of the Knee (EEFFEK Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Compare the local pain reduction after a single injection of Cingal® or Monovisc® over a 6 weeks period in patients with osteoarthritis of the knee assessed with the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
研究概览
简要总结
It is a post-license, multicenter, randomized, single blind, controlled study comparing a single injection of Cingal® (study arm) with a single injection of Monovisc® (control arm).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years of age
- •Diagnosed with osteoarthritis of the knee
- •Candidate for an intra-articular injection (single joint, unilateral) of Monovisc® or Cingal® as part of their routine clinical care and in accordance with the locally approved label
排除标准
- •Previous intra-articular injection within the last 6 months from enrolment
- •Known hypersensitivity to cortico-steroids, hyaluronic acid or any component of Cingal® or Monovisc®
- •Infectious, traumatic or neoplasic component of knee pathology
- •Surgery of the knee within the last 6 months or scheduled surgery in the next two months from enrolment
- •Patients with impaired cardio-renal function, endocrine, or other diseases or conditions that use of corticosteroid is warned.
- •Patients with known bleeding disorders
- •Patient currently treated with oral steroids or opioids
- •Patients that, in the investigators' opinion, are unlikely to comply with protocol
- •Pregnant or nursing women or women who suspect they might be pregnant.
研究组 & 干预措施
Cingal®
Single 4 ml intra-articular injection of Hyaluronic Acid plus Triamcinolone Hexacetonide
干预措施: Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide) (Device)
Monovisc®
Single 4 ml intra-articular injection of Sodium Hyaluronate
干预措施: Monovisc® (Sodium hyaluronate) (Device)
结局指标
主要结局
Compare the local pain reduction after a single injection of Cingal® or Monovisc® over a 6 weeks period in patients with osteoarthritis of the knee assessed with the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
时间窗: 6 weeks post injection
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
次要结局
- Change in stiffness and physical function(6 weeks post injection)
- Overall change of WOMAC score(6 weeks post injection)
- Time to maximum WOMAC score reduction(6 weeks post injection)
- Compare the time to maximum pain reduction by treatment arm(6 weeks post injection)
- Compare the maximum pain reduction by treatment arm(6 weeks post injection)