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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02733900
Acronym
ONTF
Enrollment
34
Registered
2016-04-12
Start date
2016-02-01
Completion date
2020-12-01
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femur Head Necrosis

Keywords

aseptic osteonecrosis, femoral head, micro scanner, Raman spectrometry, MRI

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.

Interventions

PROCEDUREfemoral head removal

Sponsors

Lille Catholic University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
25 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Osseous modifications responsible of osteonecrosisthrough the study completion, an average of 18 months

Secondary

MeasureTime frameDescription
Total cross-sectional areathrough the study completion, an average of 27 monthsby 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 areathrough the study completion, an average of 27 monthsby 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 fractionthrough the study completion, an average of 27 monthsby 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 thicknessthrough the study completion, an average of 27 monthsby 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 fractionthrough the study completion, an average of 27 monthsby using a contrast-enhanced nano-CT for the subchondral trabecular bone
trabecular numberthrough the study completion, an average of 27 monthsby using a contrast-enhanced nano-CT for the subchondral trabecular bone
trabecular separationthrough the study completion, an average of 27 monthsby using a nano-CT for the subchondral trabecular bone
trabecular thicknessthrough the study completion, an average of 27 monthsby using a contrast-enhanced nano-CT for the subchondral trabecular bone
Physico-chemical composition of the trabecular subchondral bonethrough the study completion, an average of 27 monthsmineralisation, 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 edemathrough the study completion, an average of 27 monthsthis measure will be done on the T2-weighted sequences with fat suppression
Perfusion MRI sequencethrough the study completion, an average of 27 monthsmorphological 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 methodthrough the study completion, an average of 27 monthsborder of osteosclerosis, identification of a necrotic zone, extent of this zone
Evaluation of osteocyte and adipocyte viability in hematoxylin-eosin-saffron (HES) stainingthrough the study completion, an average of 27 months
Number and ramifications of sub-chondral microvessels by immuno-labeling with CD21through the study completion, an average of 27 months
Evaluation of the number of osteoclasts by TRAP (tartrate acid Phosphatase) stainingthrough the study completion, an average of 27 months
Mankin score for cartilage degradation by Safranin O stainingthrough the study completion, an average of 27 months

Countries

France

Contacts

PRINCIPAL_INVESTIGATORTristan Pascart, MD

Hospital Group of the Catholic Institute of Lille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026