Clinical trial NCT02733900: Modifications of the Subchondral Bone in Aseptic Osteonecrosis of the Femoral Head
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
Overall status: COMPLETED
Phase: NA
Conditions: Femur Head Necrosis
Keywords: aseptic osteonecrosis
femoral head
micro scanner
Raman spectrometry
MRI
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 34
Sex: MALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Osseous modifications responsible of osteonecrosis
timeFrame: through the study completion, an average of 18 months
Secondary outcomes:
measure: Total cross-sectional area
timeFrame: through the study completion, an average of 27 months
measure: cortical bone area
timeFrame: through the study completion, an average of 27 months
measure: cortical area fraction
timeFrame: through the study completion, an average of 27 months
measure: cortical thickness
timeFrame: through the study completion, an average of 27 months
measure: bone volume fraction
timeFrame: through the study completion, an average of 27 months
measure: trabecular number
timeFrame: through the study completion, an average of 27 months
measure: trabecular separation
timeFrame: through the study completion, an average of 27 months
measure: trabecular thickness
timeFrame: through the study completion, an average of 27 months
measure: Physico-chemical composition of the trabecular subchondral bone
timeFrame: through the study completion, an average of 27 months
measure: Existence and extent of edema
timeFrame: through the study completion, an average of 27 months
measure: Perfusion MRI sequence
timeFrame: through the study completion, an average of 27 months
measure: Medullary fat fraction in T1-weighted DIXON method
timeFrame: through the study completion, an average of 27 months
measure: Evaluation of osteocyte and adipocyte viability in hematoxylin-eosin-saffron (HES) staining
timeFrame: through the study completion, an average of 27 months
measure: Number and ramifications of sub-chondral microvessels by immuno-labeling with CD21
timeFrame: through the study completion, an average of 27 months
measure: Evaluation of the number of osteoclasts by TRAP (tartrate acid Phosphatase) staining
timeFrame: through the study completion, an average of 27 months
measure: Mankin score for cartilage degradation by Safranin O staining
timeFrame: through the study completion, an average of 27 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hospital Salengro CHU Lille
city: Lomme
country: France
facility: Hospital Group of the Catholic Institute of Lille
Study officials:
affiliation: Hospital Group of the Catholic Institute of Lille
name: Tristan Pascart, MD
role: PRINCIPAL_INVESTIGATOR
References: