NCT00826098已完成4 期
Platelet Rich Plasma (PRP) in Total Knee Replacement: A Prospective, Randomized, Single-blind, Single-center Clinical Study to Evaluate the Effect of Platelet Rich Plasma (PRP) on Short-term Patient Outcomes Following Total Knee Replacement
Exactech4 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2008年12月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Hemoglobin level
研究概览
简要总结
Clinical study to evaluate the effect of platelet rich plasma (PRP), a derivative of a patient's whole blood, on short-term patient outcomes following total knee replacement (TKR).
详细描述
The purpose of this clinical study is to evaluate the effect of platelet rich plasma (PRP), a derivative of a patient's whole blood, on short-term patient outcomes following total knee replacement (TKR). The hypothesis is that change in short-term hemoglobin (Hgb) levels is less dramatic in patients who undergo TKR with the addition of PRP when compared to patients who undergo TKR without PRP.
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 PRP in Total Knee.
- •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) week post-operative period although longer follow-up is 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
- •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 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 an investigational 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
Hemoglobin level
时间窗: Change in hemoglobin (Hgb) level (preop compared to postop day 2)
Hemoglobin level analysis
次要结局
未报告次要终点
研究者
研究点 (4)
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