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Completed

NCT Number: NCT02733900

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

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.

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Key information

Conditions

Femur Head Necrosis Bone Diseases Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

25 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Salengro CHU Lille, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

femoral head removal

Procedure

Primary outcomes

  1. Osseous modifications responsible of osteonecrosis

    Time frame: through the study completion, an average of 18 months

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. trabecular separation

    Time frame: through the study completion, an average of 27 months

    by using a nano-CT for the subchondral trabecular bone

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. Evaluation of osteocyte and adipocyte viability in hematoxylin-eosin-saffron (HES) staining

    Time frame: through the study completion, an average of 27 months

  14. Number and ramifications of sub-chondral microvessels by immuno-labeling with CD21

    Time frame: through the study completion, an average of 27 months

  15. Evaluation of the number of osteoclasts by TRAP (tartrate acid Phosphatase) staining

    Time frame: through the study completion, an average of 27 months

  16. Mankin score for cartilage degradation by Safranin O staining

    Time frame: through the study completion, an average of 27 months

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study title

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

Acronym: ONTF

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Apr 12, 2016
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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