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

Not Applicable

Completed

• Conditions: Femur Head Necrosis
• Interventions: Procedure: femoral head removal

• Registration Number: NCT02733900
• Lead Sponsor: Lille Catholic University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-03-23
• Study First Submitted QC: 2016-04-05
• Study First Posted: 2016-04-12
• Primary Completion: 2018-04
• Study Completion: 2020-12
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osteonecrosis group	femoral head removal	Patients with an aseptic osteonecrosis of the femoral head
Control group	femoral head removal	Patients with coxarthrosis

Primary Outcome Measures

Name	Time	Method
Osseous modifications responsible of osteonecrosis	through the study completion, an average of 18 months

Secondary Outcome Measures

Name	Time	Method
bone volume fraction	through the study completion, an average of 27 months	by using a contrast-enhanced nano-CT for the subchondral trabecular bone
Total cross-sectional area	through the study completion, an average of 27 months	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
cortical bone area	through the study completion, an average of 27 months	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
cortical area fraction	through the study completion, an average of 27 months	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
cortical thickness	through the study completion, an average of 27 months	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
Physico-chemical composition of the trabecular subchondral bone	through the study completion, an average of 27 months	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
trabecular number	through the study completion, an average of 27 months	by using a contrast-enhanced nano-CT for the subchondral trabecular bone
trabecular separation	through the study completion, an average of 27 months	by using a nano-CT for the subchondral trabecular bone
trabecular thickness	through the study completion, an average of 27 months	by using a contrast-enhanced nano-CT for the subchondral trabecular bone
Existence and extent of edema	through the study completion, an average of 27 months	this measure will be done on the T2-weighted sequences with fat suppression
Perfusion MRI sequence	through the study completion, an average of 27 months	morphological aspect of the enhancement curve, semi-quantitative parameters (slope, area under the curve, time to peak) and pharmacokinetic parameters
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	border of osteosclerosis, identification of a necrotic zone, extent of this zone
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

Trial Locations

Locations (2)

Hospital Salengro CHU Lille; 🇫🇷 Lille, France

Hospital Group of the Catholic Institute of Lille; 🇫🇷 Lomme, France