Clinical Trial: Modifications of the Subchondral Bone in Aseptic Osteonecrosis of the Femoral Head

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Lille Catholic University

Current Primary Outcome: Osseous modifications responsible of osteonecrosis [ Time Frame: through the study completion, an average of 18 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Total cross-sectional area [ Time Frame: through the study completion, an average of 18 months ]
  by using a micro scanner for the subchondral plate in necrotic zone, juxta-necrotic zone, remotely of the necrotic zone and cortical of the femoral collar
• cortical bone area [ Time Frame: through the study completion, an average of 18 months ]
  by using a micro scanner for the subchondral plate in necrotic zone, juxta-necrotic zone, remotely of the necrotic zone and cortical of the femoral collar
• cortical area fraction [ Time Frame: through the study completion, an average of 18 months ]
  by using a micro scanner for the subchondral plate in necrotic zone, juxta-necrotic zone, remotely of the necrotic zone and cortical of the femoral collar
• cortical thickness [ Time Frame: through the study completion, an average of 18 months ]
  by using a micro scanner for the subchondral plate in necrotic zone, juxta-necrotic zone, remotely of the necrotic zone and cortical of the femoral collar
• bone volume fraction [ Time Frame: through the study completion, an average of 18 months ]
  by using a micro-scanner for the subchondral trabecular bone
• trabecular number [ Time Frame: through the study completion, an average of 18 months ]
  by using a micro-scanner for the subchondral trabecular bone
• trabecular separation [ Time Frame: through the study completion, an average of 18 months ]
  by using a micro-scanner for the subchondral trabecular bone
• trabecular thickness [ Time Frame: through the study completion, an average of 18 months ]
  by using a micro-scanner for the subchondral trabecular bone
• Physico-chemical composition of the trabecular subchondral bone [ Time Frame: through the study completion, an average of 18 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
• Existence and extent of edema [ Time Frame: through the study completion, an average of 18 months ]
  this measure will be done on the T2-weighted sequences with fat suppression
• Perfusion MRI sequence [ Time Frame: through the study completion, an average of 18 months ]
  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 [ Time Frame: through the study completion, an average of 18 months ]
  border of osteosclerosis, identification of a necrotic zone, extent of this zone

Original Secondary Outcome: Same as current

Information By: Lille Catholic University

Dates:
Date Received: March 23, 2016
Date Started: February 2016
Date Completion: November 2017
Last Updated: April 5, 2016
Last Verified: April 2016