Efficacy of Viscosupplementation Associated With Intra-articular Corticosteroid Injection Versus Intra-articular Injection of Corticosteroids Alone in Osteoarthritis of Hip
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CHU de Reims
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- improving pain
研究概览
简要总结
The current management of osteoarthritis is based on non-pharmacological and pharmacological means which include intra-articular injections.
The recommendations on the management of hip osteoarthritis stipulate that intra-articular injections of corticosteroid may be considered in patients with an exacerbation not responding to oral treatments. Several recent studies show the effectiveness of intra-articular corticosteroids compared with anesthetics. The intra-articular injection of viscosupplementation alone has never been validated in this indication since controlled studies did not show efficacy over placebo. At present, viscosupplementation is considered an anti-osteoarthritic symptomatic slow-acting and its interest is not yet established in hip osteoarthritis.
详细描述
Show the superiority of intra-articular injection of viscosupplementation in combination with corticosteroid compared to intra-articular injection of corticosteroid alone in the treatment of hip osteoarthritis.
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, Investigator)
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
- •patients with hip osteoarthrosis (stage II et III according Kellgren et Lawrence)
- •walking alone patients
- •patient consenting to participate to the study
- •patient enrolled in the national healthcare insurance program
- •patient older than 18 years
排除标准
- •Patients with hip osteoarthrosis (stage I et IV according Kellgren et Lawrence)
- •patients with rapidly destructive hip osteoarthritis
- •patients with inflammatory rheumatism
- •patients with microcrystalline arthritis
- •patients with hip osteonecrosis
- •patients who received corticosteroids during the previous three months
- •patients who received a intra articular injection of viscosupplementation during the previous six months
- •patient with haemostatic disorder
- •patient with consumption of painkillers tier 3
研究组 & 干预措施
injection of viscosupplementation and corticosteroid
experimental group
干预措施: Experimental group (Device)
injection of corticosteroid
control group
干预措施: control group (Device)
结局指标
主要结局
improving pain
时间窗: 3 months
decrease of 20 mm on a visual analog pain scale between the evaluation at day 0 and the evaluation at 3 months
次要结局
未报告次要终点