Modifications of the Subchondral Bone in Aseptic Osteonecrosis of the Femoral Head (ONTF)

April 6, 2022 updated by: Lille Catholic University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59037
        • Hospital Salengro CHU Lille
      • Lomme, France, 59462
        • Hospital Group of the Catholic Institute of Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Osteonecrosis group
Patients with an aseptic osteonecrosis of the femoral head
Procedure: femoral head removal
OTHER: Control group
Patients with coxarthrosis
Procedure: femoral head removal

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total cross-sectional area
Time Frame: 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
through the study completion, an average of 27 months
cortical bone area
Time Frame: 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
through the study completion, an average of 27 months
cortical area fraction
Time Frame: 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
through the study completion, an average of 27 months
cortical thickness
Time Frame: 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
through the study completion, an average of 27 months
bone volume fraction
Time Frame: through the study completion, an average of 27 months
by using a contrast-enhanced nano-CT for the subchondral trabecular bone
through the study completion, an average of 27 months
trabecular number
Time Frame: through the study completion, an average of 27 months
by using a contrast-enhanced nano-CT for the subchondral trabecular bone
through the study completion, an average of 27 months
trabecular separation
Time Frame: through the study completion, an average of 27 months
by using a nano-CT for the subchondral trabecular bone
through the study completion, an average of 27 months
trabecular thickness
Time Frame: through the study completion, an average of 27 months
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
Time Frame: 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
through the study completion, an average of 27 months
Existence and extent of edema
Time Frame: through the study completion, an average of 27 months
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
Time Frame: 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
through the study completion, an average of 27 months
Medullary fat fraction in T1-weighted DIXON method
Time Frame: through the study completion, an average of 27 months
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
Time Frame: through the study completion, an average of 27 months
through the study completion, an average of 27 months
Number and ramifications of sub-chondral microvessels by immuno-labeling with CD21
Time Frame: through the study completion, an average of 27 months
through the study completion, an average of 27 months
Evaluation of the number of osteoclasts by TRAP (tartrate acid Phosphatase) staining
Time Frame: through the study completion, an average of 27 months
through the study completion, an average of 27 months
Mankin score for cartilage degradation by Safranin O staining
Time Frame: through the study completion, an average of 27 months
through the study completion, an average of 27 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lille Catholic University

Investigators

  • Principal Investigator: Tristan Pascart, MD, Hospital Group of the Catholic Institute of Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2016

Primary Completion (ACTUAL)

April 1, 2018

Study Completion (ACTUAL)

December 1, 2020

Study Registration Dates

First Submitted

March 23, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (ESTIMATE)

April 12, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 7, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-P0044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Femur Head Necrosis

Clinical Trials on femoral head removal

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe