NCT02733900已完成不适用
Study of Modifications of the Composition and Structure in the Aseptic Osteonecrosis of the Femoral Head and Etiopathogenic MRI Correlations
Lille Catholic University4 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2016年2月1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
- 34
- 试验地点
- 4
- 主要终点
- Osseous modifications responsible of osteonecrosis
研究概览
简要总结
In this study, the aim is to identify the modifications responsible for aseptic osteonecrosis of the femoral head and its structural evolution by the association of the micro scanner analysis and Raman spectrometry performed on the femoral heads removed during hip replacements. The study of femoral heads will allow the analysis of bone tissue at two different scales, both correlated with the biomechanical properties of the bone. Also, the association with preliminary MRI analysis will provide pathogenic explanations correlated to these modifications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •for experimental group:
- •Patients aged from 25 to 70 years
- •Patient with an aseptic osteonecrosis of the femoral head established by medical Imaging (CT-scan, MRI or radiography)
- •FICAT stage 3 or 4
- •osteonecrosis etiologies : alcohol, corticosteroid therapy, idiopathic
- •Surgical indication of hip prosthesis determined
- •Inclusion Criteria for control group:
- •Patients aged from 40 to 70 years
- •Patient with a primitive coxarthrosis
- •Surgical indication of hip prosthesis determined
排除标准
- •for the 2 groups:
- •Other causes of osteonecrosis (coagulopathy, barotrauma, trauma)
- •Prior fracture of the upper extremity of the femur
- •Prior cancer and hematological malignancies with bone locations
- •Prior debilitating bone diseases
- •Patient refusal to participate in the study
- •Patient who isn't affiliated to a social security regimen
研究组 & 干预措施
Control group
Other
Patients with coxarthrosis
干预措施: femoral head removal (Procedure)
Osteonecrosis group
Experimental
Patients with an aseptic osteonecrosis of the femoral head
干预措施: femoral head removal (Procedure)
结局指标
主要结局
Osseous modifications responsible of osteonecrosis
时间窗: through the study completion, an average of 18 months
次要结局
- Total cross-sectional area(through the study completion, an average of 27 months)
- cortical bone area(through the study completion, an average of 27 months)
- cortical area fraction(through the study completion, an average of 27 months)
- cortical thickness(through the study completion, an average of 27 months)
- bone volume fraction(through the study completion, an average of 27 months)
- Physico-chemical composition of the trabecular subchondral bone(through the study completion, an average of 27 months)
- trabecular number(through the study completion, an average of 27 months)
- trabecular separation(through the study completion, an average of 27 months)
- trabecular thickness(through the study completion, an average of 27 months)
- Existence and extent of edema(through the study completion, an average of 27 months)
- Perfusion MRI sequence(through the study completion, an average of 27 months)
- Evaluation of osteocyte and adipocyte viability in hematoxylin-eosin-saffron (HES) staining(through the study completion, an average of 27 months)
- Medullary fat fraction in T1-weighted DIXON method(through the study completion, an average of 27 months)
- Number and ramifications of sub-chondral microvessels by immuno-labeling with CD21(through the study completion, an average of 27 months)
- Evaluation of the number of osteoclasts by TRAP (tartrate acid Phosphatase) staining(through the study completion, an average of 27 months)
- Mankin score for cartilage degradation by Safranin O staining(through the study completion, an average of 27 months)
研究者
研究点 (4)
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