Screening for Biomarkers of Osteonecrosis of the Femoral Head (NCT07545616) | Clinical Trial Compass
RecruitingNot Applicable
Screening for Biomarkers of Osteonecrosis of the Femoral Head
China300 participantsStarted 2026-04-20
Plain-language summary
Osteonecrosis of the femoral head (ONFH) presents a rapidly progressive natural disease course. Femoral head collapse may occur within two years, ultimately necessitating total hip arthroplasty and imposing a heavy medical and economic burden on patients. Early intervention can significantly improve the long-term prognosis of ONFH. However, due to the lack of validated biomarkers for early diagnosis, the early diagnostic rate remains low, with a primary diagnostic rate of merely 68.43% at the first visit, accompanied by a high rate of misdiagnosis. This project intends to collect blood samples from patients diagnosed with ONFH and suspected cases in the orthopedic outpatient department of a tertiary Grade A hospital. Diagnostic and differential diagnostic tests will be adopted to evaluate the clinical application value of previously reported candidate biomarkers, so as to screen out biomarkers with excellent diagnostic validity and reliability. Meanwhile, clinical data will be collected to identify independent risk factors, and a multi-dimensional integrated diagnostic model will be further established. The research findings are expected to provide solid data support, theoretical basis and technical reserves for the early prevention, early diagnosis and individualized intervention of osteonecrosis of the femoral head.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
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
. Aged between 18 and 70 years old (inclusive).
. Patients with suspected ONFH.
. Those who provide informed consent and volunteer to participate in this study.
Exclusion criteria
. Patients with a clear history of hip trauma.
. Patients with ONFH secondary to traumatic factors such as femoral neck fracture and hip dislocation.
. Patients complicated with severe mental illness or cognitive impairment who are unable to cooperate with questionnaire completion.
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
Disease Diagnose based on MRI
Timeframe: on enrollment
2
Diagnostic biomarkers
Timeframe: About 100 days after all sample collected.
Trial details
NCT IDNCT07545616
SponsorThe First Affiliated Hospital of Xinxiang Medical College