Modifications of the Subchondral Bone in Aseptic Osteonecrosis of the Femoral Head (NCT02733900) | Clinical Trial Compass
CompletedNot Applicable
Modifications of the Subchondral Bone in Aseptic Osteonecrosis of the Femoral Head
France34 participantsStarted 2016-02
Plain-language 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.
Who can participate
Age range
25 Years – 70 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Osseous modifications responsible of osteonecrosis
Timeframe: through the study completion, an average of 18 months