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

Primary Purpose

Femur Head Necrosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
femoral head removal
Sponsored by
Lille Catholic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Femur Head Necrosis focused on measuring aseptic osteonecrosis, femoral head, micro scanner, Raman spectrometry, MRI

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Salengro CHU Lille
  • Hospital Group of the Catholic Institute of Lille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Osteonecrosis group

Control group

Arm Description

Patients with an aseptic osteonecrosis of the femoral head

Patients with coxarthrosis

Outcomes

Primary Outcome Measures

Osseous modifications responsible of osteonecrosis

Secondary Outcome Measures

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
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
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
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
bone volume fraction
by using a contrast-enhanced nano-CT for the subchondral trabecular bone
trabecular number
by using a contrast-enhanced nano-CT for the subchondral trabecular bone
trabecular separation
by using a nano-CT for the subchondral trabecular bone
trabecular thickness
by using a contrast-enhanced nano-CT for the subchondral trabecular bone
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
Existence and extent of edema
this measure will be done on the T2-weighted sequences with fat suppression
Perfusion MRI sequence
morphological aspect of the enhancement curve, semi-quantitative parameters (slope, area under the curve, time to peak) and pharmacokinetic parameters
Medullary fat fraction in T1-weighted DIXON method
border of osteosclerosis, identification of a necrotic zone, extent of this zone
Evaluation of osteocyte and adipocyte viability in hematoxylin-eosin-saffron (HES) staining
Number and ramifications of sub-chondral microvessels by immuno-labeling with CD21
Evaluation of the number of osteoclasts by TRAP (tartrate acid Phosphatase) staining
Mankin score for cartilage degradation by Safranin O staining

Full Information

First Posted
March 23, 2016
Last Updated
April 6, 2022
Sponsor
Lille Catholic University
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1. Study Identification

Unique Protocol Identification Number
NCT02733900
Brief Title
Modifications of the Subchondral Bone in Aseptic Osteonecrosis of the Femoral Head
Acronym
ONTF
Official Title
Study of Modifications of the Composition and Structure in the Aseptic Osteonecrosis of the Femoral Head and Etiopathogenic MRI Correlations
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lille Catholic University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femur Head Necrosis
Keywords
aseptic osteonecrosis, femoral head, micro scanner, Raman spectrometry, MRI

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Osteonecrosis group
Arm Type
Experimental
Arm Description
Patients with an aseptic osteonecrosis of the femoral head
Arm Title
Control group
Arm Type
Other
Arm Description
Patients with coxarthrosis
Intervention Type
Procedure
Intervention Name(s)
femoral head removal
Primary Outcome Measure Information:
Title
Osseous modifications responsible of osteonecrosis
Time Frame
through the study completion, an average of 18 months
Secondary Outcome Measure Information:
Title
Total cross-sectional area
Description
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
Time Frame
through the study completion, an average of 27 months
Title
cortical bone area
Description
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
Time Frame
through the study completion, an average of 27 months
Title
cortical area fraction
Description
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
Time Frame
through the study completion, an average of 27 months
Title
cortical thickness
Description
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
Time Frame
through the study completion, an average of 27 months
Title
bone volume fraction
Description
by using a contrast-enhanced nano-CT for the subchondral trabecular bone
Time Frame
through the study completion, an average of 27 months
Title
trabecular number
Description
by using a contrast-enhanced nano-CT for the subchondral trabecular bone
Time Frame
through the study completion, an average of 27 months
Title
trabecular separation
Description
by using a nano-CT for the subchondral trabecular bone
Time Frame
through the study completion, an average of 27 months
Title
trabecular thickness
Description
by using a contrast-enhanced nano-CT for the subchondral trabecular bone
Time Frame
through the study completion, an average of 27 months
Title
Physico-chemical composition of the trabecular subchondral bone
Description
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
Time Frame
through the study completion, an average of 27 months
Title
Existence and extent of edema
Description
this measure will be done on the T2-weighted sequences with fat suppression
Time Frame
through the study completion, an average of 27 months
Title
Perfusion MRI sequence
Description
morphological aspect of the enhancement curve, semi-quantitative parameters (slope, area under the curve, time to peak) and pharmacokinetic parameters
Time Frame
through the study completion, an average of 27 months
Title
Medullary fat fraction in T1-weighted DIXON method
Description
border of osteosclerosis, identification of a necrotic zone, extent of this zone
Time Frame
through the study completion, an average of 27 months
Title
Evaluation of osteocyte and adipocyte viability in hematoxylin-eosin-saffron (HES) staining
Time Frame
through the study completion, an average of 27 months
Title
Number and ramifications of sub-chondral microvessels by immuno-labeling with CD21
Time Frame
through the study completion, an average of 27 months
Title
Evaluation of the number of osteoclasts by TRAP (tartrate acid Phosphatase) staining
Time Frame
through the study completion, an average of 27 months
Title
Mankin score for cartilage degradation by Safranin O staining
Time Frame
through the study completion, an average of 27 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tristan Pascart, MD
Organizational Affiliation
Hospital Group of the Catholic Institute of Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Salengro CHU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hospital Group of the Catholic Institute of Lille
City
Lomme
ZIP/Postal Code
59462
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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