Intra-articular Hyaluronic Acid Knee Injection: Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Lower extremity functional scale
研究概览
简要总结
Study design:
Allocation: Randomized. Endpoint Classification: Comparative Study. Intervention model: Parallel Assignment. Masking: Double Blind (Subject, Assessed) Primary purpose: Comparison.
Official Title: Intra-articular hyaluronic acid knee injection: randomized control trail.
Primary outcome measures:
- Lower extremity functional scale
- Visual analogue scale
- Range of motion
- Kellgren and Lawrence class grade Estimated enrollment: 100 Study start date: December 2012 Estimated study completion date: June 2013 Estimated primary completion date: December 2013
详细描述
The study include:
200 knees, 50 knees will have single injection of Crespine gel, and 50 knees will have single injection of 2 ampules of Intragel, also 50 knees will have single injection of Crespine plus gel and 50 knees will have single injection of Monovisc The patient will be randomized to Crespine gel or to Intragel, and Crespine Plus gel or to Monovisc
Inclusion Criteria: patients with Osteoarthritis grade II and III according to Kellgren and Lawrence grading were included.
Exclusion Criteria: patients with autoimmune illnesses, active inflammation or infected processes, anticoagulant, and known allergy to hyaluronic acid.
Target parameters:
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of patients between 20 and 70 years
- •patients with Osteoarthritis grade II and III according to Kellgren and Lawrence grading
排除标准
- •Autoimmune illnesses
- •Active inflammation or infected processes
- •Anticoagulant
- •Known allergy to hyaluronic acid.
研究组 & 干预措施
Group 1
50 Knees will have single injection of Crespine gel
干预措施: Crespine gel (Drug)
Group 2
50 Knees will have single injection of 2 ampules of intragel
干预措施: Intragel (Drug)
Group 3
50 knees will have single injection of crespine plus gel
干预措施: Crespine plus gel (Drug)
Group 4
50 knees will have single injection of Monovisc
干预措施: Monovisc (Drug)
结局指标
主要结局
Lower extremity functional scale
时间窗: up to 52 weeks
次要结局
- Visual analog scale(up to 52 weeks)
- Kellgren and lawrence class grade(up to 52 weeks)
- Range of motion(up to 52 weeks)
研究者
Mahmoud A Hafez, MSc Orth, Dip SICOT, FRCS Ed, MD
Mahmoud A Hafez
October 6 University