NCT01075230终止不适用
A Prospective, Randomized, Single-blind, Multi-center Clinical Study to Evaluate the Effect of Platelet Rich Plasma (PRP) on Short-term Patient Outcomes Following Total Knee Replacement.
Exactech2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in hemoglobin (Hgb) level
研究概览
简要总结
Clinical study to determine if there is a difference in hemoglobin level between patients undergoing total knee arthroplasty with and without platelet-rich plasma.
详细描述
The purpose of this study is to determine if there is a difference in hemoglobin level between patients undergoing total knee arthroplasty with and without platelet-rich plasma.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is a male or female who is undergoing primary unilateral surgery or the first surgery of a staged bilateral total knee replacement where the second stage will be at least 6 weeks later
- •Patient agrees to be blinded to their treatment group assignment
- •Patient is willing and able to return for follow-up over at least a six (6) month post-operative period although longer follow-up may be desired
- •Patient agrees to participate by signing an IRB approved Informed Consent Form
排除标准
- •Patient will have a staged bilateral total knee replacement with the second stage to be performed less than 6 weeks after the first stage surgery PRP in
- •Patient has had previous surgery on the operative knee that will necessitate the removal of existing hardware (e.g. previous osteotomy)
- •Patient has a known adverse reaction or sensitivity to bovine (cow) thrombin (used as part of the platelet rich plasma system) or other bovine-derived products
- •Patient has hemoglobin < 12.0 (males), < 11.0 (females)
- •Patient has a clinically significant anxiety disorder
- •Patient is on therapeutic anticoagulation medication and has an INR > 1.3
- •Patient has a severe bleeding disorder
- •Patient has a known addiction to drugs or alcohol, including, but not limited to: chronic daily use of narcotic medications for more than 90 days prior to surgery
- •Patient is pregnant
- •Patient is a prisoner
- •Patient is involved in a personal litigation (e.g. Worker's Compensation) that relates to their knee surgery
- •Patient is actively participating in another medical device, drug, or biologic clinical trial (active defined as having treatment within the last 30 days)
结局指标
主要结局
Change in hemoglobin (Hgb) level
时间窗: Preop, post-op day 2
Hemoglobin level analysis
次要结局
- Visual analog scale (VAS) for pain(Preop, post-op day 1, post-op day 2, discharge, 6 weeks)
研究者
研究点 (2)
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