About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged between 18 and 70 years old (inclusive).
Patients with suspected ONFH.
Those who provide informed consent and volunteer to participate in this study.
Disqualifiers
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.
Patients who refuse to sign the informed consent form.
Trial population
patients with suspected osteonecrosis of the femoral head.
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Disease Diagnose based on MRI
MRI was adopted as the gold standard for the diagnosis of ONFH.
Diagnostic biomarkers
To screen potential early diagnostic biomarkers of ONFH in human blood
Sponsors and contacts
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