RecruitingNCT07545616

Screening for Biomarkers of Osteonecrosis of the Femoral Head

Screening of Biomarkers for Osteonecrosis of the Femoral Head and Establishment of a Multidimensional Data Based Early Diagnostic Method


Sponsor

The First Affiliated Hospital of Xinxiang Medical College

Enrollment

300 participants

Start Date

Apr 20, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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.

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Locations(1)

The First Affiliated Hospiatl of Henan Medical University

Xinxiang, Henan, China

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NCT07545616


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