Actively Recruiting

Age: 18Years - 70Years
All Genders
ID07545616

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

Led by The First Affiliated Hospital of Xinxiang Medical College · Updated on 2026-04-22

300

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Osteonecrosis of the Femoral Head (ONFH) is a rapidly progressing disease where the blood supply interruption causes bone cell death, often leading to femoral head collapse within two years and the need for total hip replacement. The study focuses on improving early diagnosis of ONFH by evaluating potential blood biomarkers and creating a comprehensive diagnostic model. Early detection is crucial as current diagnosis rates at the first visit are low, with high misdiagnosis rates often confusing ONFH with other conditions like lumbar disc herniation or arthritis. This observational study plans to collect blood samples and clinical data from patients suspected of having ONFH, including various types such as alcohol-induced and steroid-induced, primarily in early disease stages. Patients with similar symptoms but different diseases will also be included for comparison. The study will use diagnostic and differential tests to assess previously reported candidate biomarkers and identify reliable markers with strong diagnostic value. Participants will undergo diagnostic evaluation including MRI at enrollment, and blood samples will be collected for biomarker analysis approximately 100 days later. The study aims to identify independent risk factors and develop an integrated diagnostic method combining clinical, biochemical, genetic, and biomechanical data. The study duration and follow-up details are based on sample collection timing and diagnostic assessments to support early prevention, diagnosis, and personalized treatment for ONFH.

CONDITIONS

Brief Title

Screening for Biomarkers of Osteonecrosis of the Femoral Head

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 18 and 70 years old (inclusive).
  • Patients with suspected osteonecrosis of the femoral head (ONFH).
  • Provide informed consent and volunteer to participate in the study.
Not Eligible

You will not qualify if you...

  • History of hip trauma.
  • ONFH caused by traumatic factors such as femoral neck fracture or hip dislocation.
  • Severe mental illness or cognitive impairment that prevents cooperation with questionnaires.
  • Refusal to sign the informed consent form.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo diagnostic procedures including MRI to confirm the presence of osteonecrosis of the femoral head at enrollment.

1 visit (in-person)

Long-term Monitoring

Duration - About 100 days after all samples are collected

Participants are observed over time with collection of clinical imaging data and biological samples to identify diagnostic biomarkers for osteonecrosis of the femoral head.

Additional visits as needed for sample collection and assessments

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospiatl of Henan Medical University

Xinxiang, Henan, China, 453003

Actively Recruiting

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Research Team

W

Wenjie Ren

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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