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临床试验/NCT03176641
NCT03176641已完成不适用

Efficacy of Platelet-rich Plasma on Meniscus Repair- a Randomized Controlled Trial

Pei-Yuan Lee, MD2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年8月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
3-month postoperative knee function evaluated by IKDC

研究概览

简要总结

This study aims to evaluate the effect of platelet-rich plasma (PRP) on meniscus injury by comparing the imaging and clinical outcomes between patients receiving PRP with meniscus repair surgery and those receiving meniscus repair surgery only.

详细描述

Damage to meniscal tissue is challenging for orthopedic surgeons because of the absence of healing at the avascular zone. Additionally, the accelerated degeneration of articular cartilage and increased rate of knee osteoarthritis that can occur following a meniscal injury. Platelet-rich plasma (PRP) is a fraction of plasma that contains platelets and multiple growth factors concentrated at high level. Because activated platelets have the potential to release growth factors, PRP has been clinically used to accelerate wound healing and tissue regeneration in orthopedic and oral surgery. Several in vivo and in vitro studies have reported favorable outcomes of PRP on meniscal repair; however, the clinical results varied between studies.This clinical trial will investigate the effect of PRP on on meniscus injury. Eligible patients will be randomly assigned to receive PRP with meniscus repair surgery or to receive meniscus repair surgery only. The postoperative imaging and clinical outcomes will be compared and analyzed.

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 (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 20 and 60 years
  • With diagnosis of meniscus injury
  • With indications of meniscus repair surgery

排除标准

  • Multiple ligaments injury
  • with prior history of knee surgery
  • Cancer patients
  • Pregnancy
  • Patients who will not cooperate with one-year followup

研究组 & 干预措施

Control group

Placebo Comparator

30 patients will receive meniscus repair surgery only.

干预措施: control (Other)

PRP group

Active Comparator

30 patients will receive autologous platelet-rich plasma gel during meniscus repair surgery.

干预措施: platelet-rich plasma (Other)

结局指标

主要结局

3-month postoperative knee function evaluated by IKDC

时间窗: 3-month postoperative

Knee function is evaluated using International Knee Documentation Committee (IKDC) score.

次要结局

  • 6-month postoperative knee function evaluated by IKDC(6-month postoperative)
  • 3-month postoperative knee pain evaluated by VAS(3-month postoperative)
  • Percentage of patients with healed meniscus 6-month postoperative(6-month postoperative)
  • Percentage of patients with healed meniscus 12-month postoperative(12-month postoperative)
  • 6-month postoperative knee pain evaluated by VAS(6-month postoperative)
  • 12-month postoperative knee pain evaluated by VAS(12-month postoperative)
  • 12-month postoperative knee function evaluated by IKDC(12-month postoperative)

研究者

发起方
Pei-Yuan Lee, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pei-Yuan Lee, MD

Superintendent

Show Chwan Memorial Hospital

研究点 (2)

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