Screening for Biomarkers of Osteonecrosis of the Femoral Head

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorThe First Affiliated Hospital of Xinxiang Medical College

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

Qualifiers

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 design

Treatments tested in this trial

  • Not listed

Trial groups

300 Participants
are grouped into 1 trial group