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

Lille Catholic University4 sites in 1 country34 target enrollmentFebruary 1, 2016

ConditionsFemur Head Necrosis

Interventionsfemoral head removal

Overview

Phase: Not Applicable
Intervention: femoral head removal
Conditions: Femur Head Necrosis
Sponsor: Lille Catholic University
Enrollment: 34
Locations: 4
Primary Endpoint: Osseous modifications responsible of osteonecrosis
Status: Completed
Last Updated: 12 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

February 1, 2016

End Date

December 1, 2020

Last Updated

12 days ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Lille Catholic University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

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

Arms & Interventions

Control group

Patients with coxarthrosis

Intervention: femoral head removal

Osteonecrosis group

Patients with an aseptic osteonecrosis of the femoral head

Intervention: femoral head removal

Outcomes

Primary Outcomes

Osseous modifications responsible of osteonecrosis

Time Frame: through the study completion, an average of 18 months

Secondary Outcomes

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)