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临床试验/NCT01406821
NCT01406821已完成不适用

Randomized, Double-blind Clinical Trial of Platelet Rich Plasma for Treatment of Acute and Chronic Patellar Tendinosis

Stanford University3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
3
主要终点
Patient-reported improvement in symptoms at 12 weeks

研究概览

简要总结

Platelet rich plasma has been used in previous studies to stimulate faster healing of torn ligaments and tendons in order to help reduce pain and restore normal function. This study aims to prove that non-operative treatment of acute and chronic ligament and tendon injuries with platelet rich plasma will reduce the time needed for participants to heal these injuries and restore function.

We are currently enrolling patients with PATELLAR TENDON INJURIES in the KNEE.

详细描述

Pre-procedure diagnosis: The appropriate clinical evaluation will be dictated by the examining physician. Minimal pre-procedure studies will include plain radiographs and MRI. All patients will complete a pretreatment questionnaire.

Patients will be randomized and blinded to a treatment regimen.

Method of randomization: Some of the participating subjects will receive platelet rich plasma and others will receive a saline injection. The platelet rich plasma experimental group will have up to 50cc of whole blood collected via venipuncture and prepared using the standard PRP protocol.

To blind the control group these patients will have a simulated needle stick and approximately 10 ml (2 teaspoons) of blood will be drawn. No blood will be given back to the patient. For those in the control group their ligament or tendon will be stimulated with dry needling (moving a needle up and down in the tendon, without injection). Patients in the PRP treatment group will also have dry needling, plus the PRP will be injected into the tendon as well.

Platelet rich plasma injections have an equivalent risk profile to routine injections. Those potential risks include skin discoloration, pain at injection site, superficial or deep infection, no relief of symptoms, worsening of symptoms, and damage to nerve and blood vessels. Potential benefits include significant improvement in symptoms and reduction in time for return to function.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute or chronic ligament or tendon injuries

排除标准

  • Pregnant women,
  • children,
  • other injuries that require surgical intervention,
  • associated fractures,
  • systemic disease resulting in an immunocompromised state affecting ability to heal soft tissues

研究组 & 干预措施

Dry needling

Sham Comparator

Blood will be drawn, and tendon will be penetrated with dry needle. Nothing will be injected into the tendon.

干预措施: Ultrasound-guided dry needling (Procedure)

Platelet-rich plasma (PRP)

Experimental

Blood will be drawn, and platelet-rich plasma will be injected into the tendon.

干预措施: Ultrasound-guided platelet-rich-plasma (PRP) injection (Procedure)

结局指标

主要结局

Patient-reported improvement in symptoms at 12 weeks

时间窗: 12 weeks

次要结局

  • Reduction in patellar tendinosis by MRI(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jason L. Dragoo

Associate Professor

Stanford University

研究点 (3)

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