NCT07545616

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026May 2027

First Submitted

Initial submission to the registry

April 15, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2027

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 15, 2026

Last Update Submit

April 15, 2026

Conditions

Osteonecrosis of the Femoral Head

Keywords

Osteonecrosis of the Femoral HeadBiomarker

Outcome Measures

Primary Outcomes (2)

  • Disease Diagnose based on MRI

    MRI was adopted as the gold standard for the diagnosis of ONFH.

    on enrollment

  • Diagnostic biomarkers

    To screen potential early diagnostic biomarkers of ONFH in human blood

    About 100 days after all sample collected.

Study Arms (1)

Patients with suspected ONFH

The research subjects shall cover as many types of ONFH patients as possible, including the alcohol-induced type, steroid-induced type and other types. Enrolled patients will be predominantly in the early stage of ONFH. Meanwhile, patients with diseases sharing similar clinical manifestations with ONFH and prone to misdiagnosis shall also be included.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with suspected osteonecrosis of the femoral head.

You may qualify if:

  • Aged between 18 and 70 years old (inclusive).
  • Patients with suspected ONFH.
  • Those who provide informed consent and volunteer to participate in this study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospiatl of Henan Medical University

Xinxiang, Henan, 453003, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum and sediment

MeSH Terms

Conditions

Legg-Calve-Perthes Disease

Condition Hierarchy (Ancestors)

Femur Head NecrosisOsteonecrosisBone DiseasesMusculoskeletal Diseases

Study Officials

  • Wenjie Ren

    The First Affliated Hosptal of Henan Medical University

    STUDY CHAIR

Central Study Contacts

Wenjie Ren

CONTACT

8618937302619157121431@qq.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 22, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

May 30, 2027

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations

CN(1)