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临床试验/NCT03787329
NCT03787329Unknown不适用

The Effect of Autologous Bone Marrow Concentration Combined With Core Decompression for Avascular Necrosis of Femoral Head

Pei-Yuan Lee, MD1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年4月14日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
3-month postoperative hip function evaluated by Harris Hip Score

研究概览

简要总结

This study aims to evaluate the effect of bone marrow concentration on avascular necrosis of femur head by comparing clinical and imaging outcomes between patients receiving core decompression surgery with intraoperative bone marrow concentration and those receiving core decompression surgery only.

详细描述

Avascular necrosis (AVN) of femoral head is a progressive disease that predominantly affects younger patients. Although the exact pathophysiology of AVN has not yet to be elucidated, the disease is characterized by a vascular insult to the blood supply of the femoral head, which can lead to collapse of the femoral head and subsequent degenerative changes. Mesenchymal stem cells (MSCs) are pluripotent cells that can differentiate into multiple mesenchymal tissues, including tenocytes, chondrocytes and osteoblasts, as well as being a source of multiple growth factors to establish an environment conducive to soft and hard tissue regeneration. As bone marrow concentration has high concentration of mesenchymal stem cells, several studies have applied the autologous bone marrow concentration in halting the progression of AVN of femoral head. However, a higher level of evidence for its use on patients suffering from femoral head avascular necrosis has not been reported. This clinical trial will evaluate and compare the eligible patients who undertake core decompression surgery plus intraoperative bone marrow concentration with those who received core decompression surgery only. All patients will be followed for one year and clinical and imaging outcomes will be compared and analyzed.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Age between 30 and 60 years
  • With diagnosis of avascular necrosis of femoral head, Stage I - Stage III

排除标准

  • With diagnosis of avascular necrosis of femoral head, Stage VI - Stage VI
  • With prior history of hip surgery
  • With current or prior history of trauma or infection at hip
  • Platelet count < 50,000/µL
  • With current diagnosis of coagulopathy
  • With current or prior history of cancer
  • With current or prior history of hematological disease
  • Pregnancy
  • Patients who will not cooperate with one-year followup

结局指标

主要结局

3-month postoperative hip function evaluated by Harris Hip Score

时间窗: 3-month postoperative

Hip function is evaluated using Harris Hip score. The survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.

次要结局

  • 6-month postoperative degree of collapse evaluated by MRI(6-month postoperative)
  • 6-month postoperative hip function evaluated by Harris Hip Score(6-month postoperative)
  • 12-month postoperative hip function evaluated by Harris Hip Score(12-month postoperative)
  • 6-month postoperative degree of collapse evaluated by plain radiograph(6-month postoperative)
  • 12-month postoperative degree of collapse evaluated by plain radiograph(12-month postoperative)
  • 3-month postoperative degree of collapse evaluated by plain radiograph(3-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 (1)

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