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

NCT ID: NCT02733900

Last Updated: 2022-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2020-12-31

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.

Conditions

Femur Head Necrosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Osteonecrosis group

Patients with an aseptic osteonecrosis of the femoral head

Group Type: EXPERIMENTAL

femoral head removal

Intervention Type: PROCEDURE

Control group

Patients with coxarthrosis

Group Type: OTHER

femoral head removal

Intervention Type: PROCEDURE

Interventions

femoral head removal

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• Men
• Patients aged from 40 to 70 years
• Patient with a primitive coxarthrosis
• Surgical indication of hip prosthesis determined

Exclusion Criteria

• 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Lille Catholic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tristan Pascart, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Group of the Catholic Institute of Lille

Locations

Hospital Salengro CHU Lille

Lille, , France

Hospital Group of the Catholic Institute of Lille

Lomme, , France

Countries

France

Other Identifiers

RC-P0044

Identifier Type: -

Identifier Source: org_study_id