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临床试验/NCT04350827
NCT04350827已完成不适用

Platelet-rich Plasma Versus Platelet-rich Plasma Plus Concentrated Insulin-like Growth Factor for Patellar Tendinosis: a Randomized Comparative Trial

Ohio State University2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2020年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Victorian Institute of Sport Assessment-patellar Tendon (VISA-P)

研究概览

简要总结

The purpose of this study is to compare two different platelet-rich plasma (PRP) injections for patellar tendinosis.

Aim: To perform a randomized, double blinded study comparing the clinical effect of PRP versus PRP + concentrated insulin-like growth factor (IGF) in patients with patellar tendinosis.

详细描述

Introduction/Background:

Patellar tendinosis is a frustrating ailment commonly encountered in sports medicine. Treating this condition continues to be a significant challenge for sports medicine physicians. The tendinosis lesion is characterized by collagen disorganization and increased ground substance. One method of treating this problem is using platelet rich plasma (PRP), which is a concentration of platelets from the patient's own blood that provides a high dose of growth factors aimed at stimulating tendon healing. These injections have been used extensively to treat many tendon disorders including patellar tendinosis. Several studies have demonstrated the safety and efficacy of using PRP to treat patellar tendinosis.

One growth factor that is known to be helpful in tendon healing is insulin-like growth factor (IGF). However, IGF is not found in PRP but rather in the free plasma that is spun off during the PRP processing. This free plasma or platelet poor plasma (PPP) is typically discarded but it is a known source of IGF. We have shown that concentrating PPP in the FDA cleared Plasmax device yields an increased concentration of insulin-like growth factor (IGF). Local IGF injections into the patellar tendon have demonstrated improved tendon healing, but the effect on clinical outcomes has never been studied in a controlled fashion.

Research Design: Double blinded randomized comparative trial.

Detailed Study Procedures: 38 patients will be randomly assigned to a treatment arm. 19 patients will receive platelet rich plasma (PRP) and 19 patients will receive PRP plus concentrated IGF. Patient will be blinded to their treatment, but treatment team will not. PRP will be prepared according to standard sterile procedures out of view of the patient to ensure patients are adequately blinded. The injecting physician will not be blinded to randomization scheme.

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
Double (Participant, 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

入选标准

  • >6 weeks of symptomatic patellar tendinosis
  • unilateral or bilateral
  • 18 yrs of age or older
  • active in sport and exercise at least 3x / week
  • able to take time away from sport (for healing and rehabilitation phase after procedure)
  • failed at least 6 weeks of guided rehabilitation (under the supervision of either a certified athletic trainer or physical therapist)
  • minimum Tegner activity level of 4

排除标准

  • Steroid injection in target knee in the last 3 months
  • PRP in the target knee in the last 6 months
  • No other cellular treatments in index knee (bone marrow, amniotic suspensions) last 1 year
  • Participation in any experimental device or drug study within 1 year before screening visit
  • Oral or IM steroids for last 3 months
  • Dry needling of patellar tendon in last 6 months

结局指标

主要结局

Victorian Institute of Sport Assessment-patellar Tendon (VISA-P)

时间窗: 6 months

Victorian Institute of sport assessment scale for patellar tendinopathy \[VISA-P\] is a self-administered questionnaire consisting of 8 items; 6 are used to evaluate pain levels or disability in daily activities and specific functional tests and 2 provide information regarding ability to play sport. The maximum score possible is 100 points and represents an asymptomatic athlete who can fully engage in sports. The theoretical minimum is 0 points.

次要结局

  • Visual Analog Scale-Pain(6 months)
  • Tegner Activity Scale(6 months)
  • Blazina Classification(6 months)

研究者

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

Michael Baria

Assistant Professor

Ohio State University

研究点 (2)

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