NCT02833545已完成4 期
Safety and Efficacy of Intra-articular Ozone Injections for Knee Osteoarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Improvement in VAS Pain intensity
研究概览
简要总结
Prospective, Interventional, Non-Randomized, Open Label, Single Group Assignment, Single Center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
the outcome assessor was not aware of the therapy administered
入排标准
- 年龄范围
- 55 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •55 to 79 years of age
- •Symptomatic Knee osteoarthritis
- •VAS pain intensity is at least 40 mm on a 100 mm scale
- •Must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely schedule clinical and radiographic visits.
排除标准
- •Any known tumor of the ipsilateral knee.
- •Any known infection of the treated knee.
- •Osteoarthritis of the operated knee Kelgren Lawrence < grade
- •Chemotherapy treatment in the past 12 months.
- •Patients who are sensitive to ozone.
- •Pregnant women, or breastfeeding women.
- •Evidence of any significant systemic disease (such as but not limited to HIV infection, hepatitis infection or HTLV infection), known coagulopathies, that might compromise the Subject's welfare.
- •Substance abuse or alcohol abuse.
- •Participation in other clinical trials in parallel to this study.
研究组 & 干预措施
OZONE
Experimental
injection of ozone gas
干预措施: Ozone gas (Device)
control
Active Comparator
injeciton of steroids intra articularly
干预措施: Steroid injection (Drug)
结局指标
主要结局
Improvement in VAS Pain intensity
时间窗: 6 months
The outcome measure will be measured according to patient response to the question: during the last week what was your average pain intensity. The response will be measured in millimeters as marked on a 10 cm long line. No pain equals 0 mm and maximal possible pain equals 100mm
次要结局
未报告次要终点
研究者
DROR ROBINSON
Head Orthopedic Research Unit
Rabin Medical Center
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