临床试验/NCT01613612

NCT01613612Unknown2 期

Control Study of Implantation of Enriched Bone Marrow Cells for the Treatment of Avascular Necrosis of Femoral Head

Guangdong Provincial People's Hospital0 个研究点目标入组 60 人开始时间: 2009年3月最近更新: 2012年8月14日

适应症

试验速览

阶段: 2 期
发起方: Guangdong Provincial People's Hospital
入组人数: 60
主要终点: change of Visual Analogue Scale

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to compare the efficacy of autologous enriched bone marrow cell implantation combined with core decompression to single core decompression for the treatment of avascular necrosis of femoral head.

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 55 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•femoral head necrosis patients
•stage I/II/III (Ficat)
•age from 18 to 55 years
•stop steroid treatment for minimal 6 months

排除标准

•age younger than 18 or older than 55
•any hemopathy
•femoral head/neck fracture

结局指标

主要结局

change of Visual Analogue Scale

时间窗: before invention and 24 months after invention

Change from baseline in 24 months

change of lequensne algofunctional index

时间窗: before invention and 24 months after invention

change from baseline in 24 months

change of WOMAC index

时间窗: before invention and 24 months after invention

change from baseline in 24 months

次要结局

未报告次要终点

研究者

发起方

Guangdong Provincial People's Hospital

申办方类型

Other

责任方

Principal Investigator

主要研究者

Qiujiang Zheng

Director of Orthopaedic Surgery

Guangdong Provincial People's Hospital

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