Biomarker screening to detect early femoral head osteonecrosis
Screening of Biomarkers for Osteonecrosis of the Femoral Head and Establishment of a Multidimensional Data Based Early Diagnostic Method
This project will test whether blood biomarkers can help detect osteonecrosis of the femoral head earlier in adults who are suspected to have the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Xinxiang Medical College Academic / other |
| Locations | 1 site (Xinxiang, Henan) |
| Trial ID | NCT07545616 on ClinicalTrials.gov |
What this trial studies
Osteonecrosis of the femoral head (ONFH) often progresses quickly to femoral head collapse and may require total hip arthroplasty. This observational project will collect blood samples and clinical data from adults aged 18–70 with diagnosed or suspected ONFH seen in the orthopedic outpatient department of a tertiary Grade A hospital. Investigators will test previously reported candidate blood biomarkers using diagnostic and differential analyses to identify markers with strong diagnostic validity and reliability. The overall aim is to find biomarkers that improve early diagnosis and reduce misdiagnosis rates.
Who should consider this trial
Good fit: Adults aged 18–70 who are diagnosed with or suspected to have ONFH and who can provide informed consent are the ideal candidates for this project.
Not a fit: Patients with ONFH clearly caused by hip trauma or those unable to cooperate due to severe mental illness or cognitive impairment are unlikely to benefit from this biomarker screening.
Why it matters
Potential benefit: If successful, validated blood biomarkers could enable earlier diagnosis and treatment, reducing femoral head collapse and the need for hip replacement.
How similar studies have performed: Some candidate biomarkers have been reported in prior work but none are yet widely validated, so previous results are suggestive but not definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged between 18 and 70 years old (inclusive). 2. Patients with suspected ONFH. 3. Those who provide informed consent and volunteer to participate in this study. Exclusion Criteria: 1. Patients with a clear history of hip trauma. 2. Patients with ONFH secondary to traumatic factors such as femoral neck fracture and hip dislocation. 3. Patients complicated with severe mental illness or cognitive impairment who are unable to cooperate with questionnaire completion. 4. Patients who refuse to sign the informed consent form.
Where this trial is running
Xinxiang, Henan
- The First Affiliated Hospiatl of Henan Medical University — Xinxiang, Henan, China (Recruiting)
Study contacts
- Study coordinator: Wenjie Ren
- Email: 157121431@qq.com
- Phone: 8618937302619
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.