NCT01472913已完成4 期
Fibrin Sealant in Bilateral Simultaneous Total Knee Arthroplasty. A Prospective Randomised Double-blinded Study Focus in on: Blood Loss, Pain, ROM, Swelling and Strength
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
- 48
- 试验地点
- 1
- 主要终点
- Blood loss
研究概览
简要总结
The purpose of this study is to measure the effect of fibrin sealant on reducing blood loss, pain and swelling when operated for bilateral total knee arthroplasty. Likewise the effect on Range Of Movement (ROM) and strength is examined.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Elective bilateral knee arthroplasty
- •Must speak and understand Danish
- •Musk be able to gave oral and written consent.
- •Females must be post-menopausal, and last menstruation must be minimum of one year ago.
排除标准
- •Alcohol or medicine abuse
- •Treatment with opioids
- •Allergy to local anaesthetics
- •Allergy to active substances i fibrin sealant
- •Age below 18
研究组 & 干预措施
Fibrin Sealent
Active Comparator
干预措施: Fibrin sealant (Drug)
Saline water
Placebo Comparator
干预措施: Saline water (Drug)
结局指标
主要结局
Blood loss
时间窗: 24 hours postoperative
24 hours postopertive blood loss estimated by drains from each of the knees .
次要结局
- swelling(2-3 weeks before surgery and 1st, 2nd, 3rd, 7th and 21st postoperative day)
- Pain(2-3 weeks before the operation and on 1st, 2nd, 3rd, 7th and 21st postoperative day.)
- Range of Movement (ROM)(2-3 weeks before surgery and on the 3rd, 7th and 21st postoperative day)
- Strength(2-3 weeks before the operation and on the 3rd, 7th and 21st postoperative day)
研究者
Christian Skovgaard Nielsen
M.D. Orthopedic Surgery
Hvidovre University Hospital
研究点 (1)
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