Femur Head NecrosisONTFNCT02733900
Modifications of the Subchondral Bone in Aseptic Osteonecrosis of the Femoral Head
A study testing femoral head removal in people with Femur Head Necrosis, run by Lille Catholic University at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 years, men only
- Conditions the study is for
- Femur Head Necrosis
- What is being tested?
- femoral head removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Men
- Patients aged from 40 to 70 years
- Patient with a primitive coxarthrosis
- Surgical indication of hip prosthesis determined
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hospital Salengro CHU Lille
Lille, 59037
Hospital Group of the Catholic Institute of Lille
Lomme, 59462
About this study
Official title: Study of Modifications of the Composition and Structure in the Aseptic Osteonecrosis of the Femoral Head and Etiopathogenic MRI Correlations
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
- Being tested
- femoral head removal
- Keywords
- aseptic osteonecrosis, femoral head, micro scanner, Raman spectrometry, MRI
- Medical subject headings
- Femur Head Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
femoral head removalProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Osteonecrosis group | Experimental | Patients with an aseptic osteonecrosis of the femoral head Receives: Procedure: femoral head removal |
| Control group | Other | Patients with coxarthrosis Receives: Procedure: femoral head removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osseous modifications responsible of osteonecrosis
Measured: through the study completion, an average of 18 months
Secondary outcomes (16)
Total cross-sectional area
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
Measured: through the study completion, an average of 27 months
cortical bone area
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
Measured: through the study completion, an average of 27 months
cortical area fraction
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
Measured: through the study completion, an average of 27 months
cortical thickness
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
Measured: through the study completion, an average of 27 months
bone volume fraction
by using a contrast-enhanced nano-CT for the subchondral trabecular bone
Measured: through the study completion, an average of 27 months
trabecular number
by using a contrast-enhanced nano-CT for the subchondral trabecular bone
Measured: through the study completion, an average of 27 months
trabecular separation
by using a nano-CT for the subchondral trabecular bone
Measured: through the study completion, an average of 27 months
trabecular thickness
by using a contrast-enhanced nano-CT for the subchondral trabecular bone
Measured: through the study completion, an average of 27 months
Physico-chemical composition of the trabecular subchondral bone
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
Measured: through the study completion, an average of 27 months
Existence and extent of edema
this measure will be done on the T2-weighted sequences with fat suppression
Measured: through the study completion, an average of 27 months
Perfusion MRI sequence
morphological aspect of the enhancement curve, semi-quantitative parameters (slope, area under the curve, time to peak) and pharmacokinetic parameters
Measured: through the study completion, an average of 27 months
Medullary fat fraction in T1-weighted DIXON method
border of osteosclerosis, identification of a necrotic zone, extent of this zone
Measured: through the study completion, an average of 27 months
Evaluation of osteocyte and adipocyte viability in hematoxylin-eosin-saffron (HES) staining
Measured: through the study completion, an average of 27 months
Number and ramifications of sub-chondral microvessels by immuno-labeling with CD21
Measured: through the study completion, an average of 27 months
Evaluation of the number of osteoclasts by TRAP (tartrate acid Phosphatase) staining
Measured: through the study completion, an average of 27 months
Mankin score for cartilage degradation by Safranin O staining
Measured: through the study completion, an average of 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2018
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Femur Head NecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tristan Pascart, MD, Principal investigator, Hospital Group of the Catholic Institute of Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733900
- Sponsor's protocol ID
- RC-P0044
- Acronym
- ONTF
- Status last verified
- Apr 2026
- First submitted
- 23 Mar 2016
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32871293
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Modifications of the Composition and Structure in the Aseptic Osteonecrosis of the Femoral Head and Etiopathogenic MRI Correlations
- ClinicalTrials.gov ID
- NCT02733900
- Acronym / sponsor ID
- ONTF / RC-P0044
- Conditions
- Femur Head Necrosis
- Keywords
- aseptic osteonecrosis, femoral head, micro scanner, Raman spectrometry, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteonecrosis group | Experimental | Procedure: femoral head removalPatients with an aseptic osteonecrosis of the femoral head |
| Control group | Other | Procedure: femoral head removalPatients with coxarthrosis |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| femoral head removal | Procedure or surgery | Control group, Osteonecrosis group |
Primary outcome
Osseous modifications responsible of osteonecrosis
Time frame: through the study completion, an average of 18 months
16 secondary outcomes
Total cross-sectional area
Time frame: through the study completion, an average of 27 months
cortical bone area
Time frame: through the study completion, an average of 27 months
cortical area fraction
Time frame: through the study completion, an average of 27 months
cortical thickness
Time frame: through the study completion, an average of 27 months
bone volume fraction
Time frame: through the study completion, an average of 27 months
trabecular number
Time frame: through the study completion, an average of 27 months
trabecular separation
Time frame: through the study completion, an average of 27 months
trabecular thickness
Time frame: through the study completion, an average of 27 months
Physico-chemical composition of the trabecular subchondral bone
Time frame: through the study completion, an average of 27 months
Existence and extent of edema
Time frame: through the study completion, an average of 27 months
Perfusion MRI sequence
Time frame: through the study completion, an average of 27 months
Medullary fat fraction in T1-weighted DIXON method
Time frame: through the study completion, an average of 27 months
Evaluation of osteocyte and adipocyte viability in hematoxylin-eosin-saffron (HES) staining
Time frame: through the study completion, an average of 27 months
Number and ramifications of sub-chondral microvessels by immuno-labeling with CD21
Time frame: through the study completion, an average of 27 months
Evaluation of the number of osteoclasts by TRAP (tartrate acid Phosphatase) staining
Time frame: through the study completion, an average of 27 months
Mankin score for cartilage degradation by Safranin O staining
Time frame: through the study completion, an average of 27 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Results publication: PubMed 32871293Cultot 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tristan Pascart, MD principal investigator
Hospital Group of the Catholic Institute of Lille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing femoral head removal in people with Femur Head Necrosis, run by Lille Catholic University at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osseous modifications responsible of osteonecrosis (time frame: through the study completion, an average of 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02733900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.