The Effect of Platelet Rich Plasma (PRP) on Post Operative Pain in Anterior Cruciate Ligament Reconstruction
2021年3月1日 更新者：Brian Walters
"Effect of Intraoperative Application of Autologous PRP on Post Operative Morbidity in ACL Reconstruction Using Autologous Bone Patellar Tendon Bone Graft Harvest"
The purpose of this research study is to investigate whether or not platelet rich plasma (PRP) may help to improve tendon healing and decrease post operative pain in patients undergoing anterior cruciate ligament (ACL) reconstructive surgery using their own patellar tendons as autografts.
研究概览
地位
完全的
条件
详细说明
There is currently a paucity of well-designed, prospective, randomized, blinded (Level 1) clinical studies that carefully and comprehensively investigate the role of PRP in ACL surgery. Specifically, ACL reconstruction using Bone Patellar Tendon Bone (BPTB) harvest and the role of PRP in decreasing postoperative pain at the donor site. Given the need for a highly powered study to demonstrate the clinical efficacy of PRP in ACL reconstruction, the investigators have designed a prospective, randomized, level 1, double-blinded study to evaluate the effects of PRP on the specific outcomes of donor site pain and radiographic measures of graft healing and incorporation.
The aim of this study is to evaluate the efficacy of intra-operatively applied autologous PRP in reducing donor site morbidity and increasing radiographic healing in ACL reconstruction using autologous BPTB.
研究类型
介入性
注册 (实际的)
50
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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New York
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New York、New York、美国、10021
- NY Orthopedics
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Primary ACL Reconstruction
- Outerbridge </= 2
- Minimum follow up of two years
- No ligamentous secondary injury
- Willingness to participate in study
Exclusion Criteria:
- Any previous knee injury
- prior history of anterior knee pain
- Outerbridge classification 3 or greater
- Revision ACL
- Diabetic or smoker
- Workers compensation patient
- pregnant or nursing women
- Any patient with limited English Proficiency
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：Control Group
Patients will be randomized into the treatment arm using a computer generated randomization table (simple randomization).
Patients in the control arm of the study will undergo Anterior cruciate ligament reconstruction using Autologous bone patellar tendon bone autograft.
At the end of the surgery, their graft donor site will have bone graft chips placed into the bony defect and the wound will be closed using sutures.
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其他名称：
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实验性的：Platelet Rich Plasma
Patients randomized into the treatment arm of the study will undergo Anterior cruciate ligament reconstruction with Autologous bone patellar tendon bone autografts.
At the start of the surgery,just after the administration of anesthesia, 10cc of blood will be withdrawn from the patients IV by the anesthesiologist.
This sample will be spun down into 3-5cc of Platelet Rich Plasma which will be added to the patients bone graft chips and placed into the donor site at the end of the case.
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其他名称：
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Anterior Knee Pain
大体时间：2 weeks, 1, 3, 6, 12, 18, 24 months. Kneeling pain for treatment groups at 24 months post-op reported.
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The primary outcome measured will be anterior knee pain.
The investigators will do so by using Visual Analog Scales as an assessment tool.
The visual analog scales will include pain with activities of daily living and pain with kneeling activities.
Information regarding these pain scales will be collected at 14 days and 1,3,6,12,18 and 24 months.
The Visual analog Scale is a score from 0-10 with 0=no pain and 10=excruciating pain.
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2 weeks, 1, 3, 6, 12, 18, 24 months. Kneeling pain for treatment groups at 24 months post-op reported.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Radiographic Assessment of Tunnel Positioning
大体时间：3 months
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A triple view radiographic series of the knee will be performed to assess the position of the tibial and femoral tunnels by one blinded senior radiologist.
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3 months
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Quantification of Healing at the Bony and Tendinous Harvest Sites
大体时间：6 months
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Post-op MRI's will be obtained to quantify the amount of bony healing at the donor site and revascularization of native patellar tendon at the harvest site.
These images will be interpreted by one blinded senior musculoskeletal radiologist.
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6 months
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Post Operative Strength
大体时间：3,6,12,18,24months
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The objective clinical assessment of strength in the operative extremity will measured as quadriceps strength in a single leg hop test.
This data will be collected by an independent researcher also blinded to treatment.
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3,6,12,18,24months
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Post Operative Range of Motion
大体时间：2 weeks, 1,3,6,12,18,24months
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The patients range of motion will be assessed on both the operative and non-operative knee.
This information will be assessed using a goniometer and will be collected by a blinded clinician.
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2 weeks, 1,3,6,12,18,24months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Stephen Nicholas, MD、Northwell Health
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2012年12月1日
初级完成 (实际的)
2017年8月1日
研究完成 (实际的)
2017年8月1日
研究注册日期
首次提交
2013年1月3日
首先提交符合 QC 标准的
2013年1月8日
首次发布 (估计)
2013年1月10日
研究记录更新
最后更新发布 (实际的)
2021年3月24日
上次提交的符合 QC 标准的更新
2021年3月1日
最后验证
2021年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.