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
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
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
NCT ID
NCT02733900
First Posted
March 23, 2016
Last Updated
April 6, 2022
Sponsor
Lille Catholic University
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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