Skip to content

A study on the efficacy of artificial bone filling for osteonecrosis of the femoral head

A study on the efficacy of artificial bone filling for osteonecrosis of the femoral head - A study on the efficacy of artificial bone filling for ONFH

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1022250003
Enrollment
25
Registered
2025-05-21
Start date
2025-07-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteonecrosis of the femoral head Osteonecrosis of the femoral head, artificial bone

Interventions

Under fluoroscopy, bone drilling is performed on the necrotic area of the femoral head. A bone biopsy instrument is used to remove cortical and cancellous bone from the outside of the femur. The art

Sponsors

Tanaka Hidetatsu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients diagnosed with femoral head necrosis at our hospital 1) Patients diagnosed with femoral head necrosis at Tohoku University Hospital 2) Patients who meet the following criteria according to the Ministry of Health, Labor and Welfare specific disease Idiopathic Femoral Head Necrosis Research Group: Stage 1, 2, 3A, 3B / Type B, C1, C2 3) Age 18 years or older (at time of registration) 4) Gender not important 5) Individuals who have given written consent to participate in the study 6) Surgery is possible within 18 months from the date of first diagnosis of osteonecrosis of the femoral head by X-ray and MRI, or from the date of worsening pain in patients with asymptomatic osteonecrosis of the femoral head.

Exclusion criteria

Exclusion criteria: 1) Patients who have previously undergone surgery around the target hip joint 2) Pregnant or potentially pregnant patients, or breastfeeding patients 3) Patients with tumors, tumor-like diseases, epiphyseal dysplasia, trauma (femoral neck fracture, traumatic hip dislocation, etc.), slipped capital femoral epiphysis, pelvic radiation, femoral head necrosis associated with decompression sickness, or Perthes disease 4) Patients in whom bone drilling is considered difficult due to the location of the necrotic area or the shape of the proximal femur 5) Allergy patients with a history of anaphylaxis, severe allergy patients, or patients known to have allergies to other gelatin, calcium phosphate. 6) Patients who are otherwise deemed inappropriate for participation in this study by the attending physician

Design outcomes

Primary

MeasureTime frame
Presence or absence of progression of femoral head necrosis from baseline to one year later. Femoral head necrosis was considered to have progressed if any of the following events were observed: 1) Progression in the stage classification of the Ministry of Health, Labor and Welfare's Idiopathic Femoral Head Necrosis Research Group, a specific disease; 2) Performance of total hip arthroplasty (THA). The baseline for the intervention group was the time of surgery, and for the external control group, the date on which femoral head necrosis was first diagnosed by X-ray at Tohoku University Hospital.

Secondary

MeasureTime frame
Measure the length of collapse using plain X-ray images taken before 3, 6, and 12 months after surgery, and evaluate using the stage classification. Changes in the collapse length (mm) using plain X-ray images before surgery and 3, 6, 12 months after surgery. Improvement of clinical scores Compare whether HHS and JHEQ have improved 3 months and 1 year after surgery compared to before surgery Evaluate whether the artificial bone has been transformed into bone using plain X-ray images taken before and after surgery.

Contacts

Public ContactHidetatsu Tanaka

Tohoku University Hospital

hidetatsu.tanaka.c7@tohoku.ac.jp+81-22-717-7245

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026