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

Femur Head Necrosis Clinical Trial

— ONTF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02733900
• Other study ID #: RC-P0044
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: December 2020

Study information

• Verified date: April 2022
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2020
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Femur Head Necrosis
• Necrosis
• Osteonecrosis

Intervention

Procedure:
• femoral head removal

Locations

Country	Name	City	State
France	Hospital Salengro CHU Lille	Lille
France	Hospital Group of the Catholic Institute of Lille	Lomme

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Osseous modifications responsible of osteonecrosis		through the study completion, an average of 18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	bone volume fraction	by using a contrast-enhanced nano-CT for the subchondral trabecular bone	through the study completion, an average of 27 months
Secondary	trabecular number	by using a contrast-enhanced nano-CT for the subchondral trabecular bone	through the study completion, an average of 27 months
Secondary	trabecular separation	by using a nano-CT for the subchondral trabecular bone	through the study completion, an average of 27 months
Secondary	trabecular thickness	by using a contrast-enhanced nano-CT for the subchondral trabecular bone	through the study completion, an average of 27 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Evaluation of osteocyte and adipocyte viability in hematoxylin-eosin-saffron (HES) staining		through the study completion, an average of 27 months
Secondary	Number and ramifications of sub-chondral microvessels by immuno-labeling with CD21		through the study completion, an average of 27 months
Secondary	Evaluation of the number of osteoclasts by TRAP (tartrate acid Phosphatase) staining		through the study completion, an average of 27 months
Secondary	Mankin score for cartilage degradation by Safranin O staining		through the study completion, an average of 27 months