NCT02733900

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

March 23, 2016

Last Update Submit

April 17, 2026

Conditions

Femur Head Necrosis

Keywords

aseptic osteonecrosisfemoral headmicro scannerRaman spectrometryMRI

Outcome Measures

Primary Outcomes (1)

  • Osseous modifications responsible of osteonecrosis

    through the study completion, an average of 18 months

Secondary Outcomes (16)

  • Total cross-sectional area

    through the study completion, an average of 27 months

  • cortical bone area

    through the study completion, an average of 27 months

  • cortical area fraction

    through the study completion, an average of 27 months

  • cortical thickness

    through the study completion, an average of 27 months

  • bone volume fraction

    through the study completion, an average of 27 months

  • +11 more secondary outcomes

Study Arms (2)

Osteonecrosis group

EXPERIMENTAL

Patients with an aseptic osteonecrosis of the femoral head

Procedure: femoral head removal

Control group

OTHER

Patients with coxarthrosis

Procedure: femoral head removal

Interventions

femoral head removalPROCEDURE
Control groupOsteonecrosis group

Eligibility Criteria

Age25 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Salengro CHU Lille

Lille, 59037, France

Location

Hospital Group of the Catholic Institute of Lille

Lomme, 59462, France

Location

Related Publications (1)

  • Cultot A, Norberciak L, Coursier R, Putman S, Cortet B, Paccou J, Pascart T, Budzik JF. BONE PERFUSION AND ADIPOSITY BEYOND THE NECROTIC ZONE IN FEMORAL HEAD OSTEONECROSIS: A QUANTITATIVE MRI STUDY. Eur J Radiol. 2020 Oct;131:109206. doi: 10.1016/j.ejrad.2020.109206. Epub 2020 Aug 5.

    PMID: 32871293RESULT

MeSH Terms

Conditions

Femur Head Necrosis

Condition Hierarchy (Ancestors)

OsteonecrosisBone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tristan Pascart, MD

    Hospital Group of the Catholic Institute of Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2016

First Posted

April 12, 2016

Study Start

February 1, 2016

Primary Completion

April 1, 2018

Study Completion

December 1, 2020

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)