Modifications of the Subchondral Bone in Aseptic Osteonecrosis of the Femoral Head

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Study of Modifications of the Composition and Structure in the Aseptic Osteonecrosis of the Femoral Head and Etiopathogenic MRI Correlations

Conditions
-----------------
Femur Head Necrosis

Intervention / Treatment
-----------------
* Procedure: femoral head removal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for experimental group: Men 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: Men Patients aged from 40 to 70 years Patient with a primitive coxarthrosis Surgical indication of hip prosthesis determined Exclusion Criteria 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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osteonecrosis group<br>Patients with an aseptic osteonecrosis of the femoral head | Procedure: femoral head removal<br> <br> |
| Other: Control group<br>Patients with coxarthrosis | Procedure: femoral head removal<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osseous modifications responsible of osteonecrosis |  | through the study completion, an average of 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cross-sectional area | by using a contrast-enhanced nano-CT for the subchondral plate in necrotic zone, juxta-necrotic zone, remotely of the necrotic zone and cortical of the femoral collar | through the study completion, an average of 27 months | 
| cortical bone area | by using a contrast-enhanced nano-CT for the subchondral plate in necrotic zone, juxta-necrotic zone, remotely of the necrotic zone and cortical of the femoral collar | through the study completion, an average of 27 months | 
| cortical area fraction | by using a contrast-enhanced nano-CT for the subchondral plate in necrotic zone, juxta-necrotic zone, remotely of the necrotic zone and cortical of the femoral collar | through the study completion, an average of 27 months | 
| cortical thickness | by using a contrast-enhanced nano-CT for the subchondral plate in necrotic zone, juxta-necrotic zone, remotely of the necrotic zone and cortical of the femoral collar | through the study completion, an average of 27 months | 
| bone volume fraction | by using a contrast-enhanced nano-CT for the subchondral trabecular bone | through the study completion, an average of 27 months | 
| trabecular number | by using a contrast-enhanced nano-CT for the subchondral trabecular bone | through the study completion, an average of 27 months | 
| trabecular separation | by using a nano-CT for the subchondral trabecular bone | through the study completion, an average of 27 months | 
| trabecular thickness | by using a contrast-enhanced nano-CT for the subchondral trabecular bone | through the study completion, an average of 27 months | 
| Physico-chemical composition of the trabecular subchondral bone | mineralisation, carbonation, crystallinity, secondary structure of collagen, maturity of collagen, relative content of proteoglycans. These measures will be done for the trabecular subchondral bone in necrotic zone, juxta-necrotic zone, remotely of the necrotic zone and in the cortical of the femoral collar | through the study completion, an average of 27 months | 
| Existence and extent of edema | this measure will be done on the T2-weighted sequences with fat suppression | through the study completion, an average of 27 months | 
| Perfusion MRI sequence | morphological aspect of the enhancement curve, semi-quantitative parameters (slope, area under the curve, time to peak) and pharmacokinetic parameters | through the study completion, an average of 27 months | 
| Medullary fat fraction in T1-weighted DIXON method | border of osteosclerosis, identification of a necrotic zone, extent of this zone | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, aseptic osteonecrosis, femoral head, micro scanner, Raman spectrometry