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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)

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

Tanaka Hidetatsu

Tohoku University Hospital

1-1 Seiryo-machi, Aoba-Ku, Sendai

hidetatsu.tanaka.c7@tohoku.ac.jp

Tanaka Hidetatsu

Tohoku University Hospital

1-1, seiryo-machi, aoba-ku, Sendai, Myagi

+81-22-717-7245

hidetatsu.tanaka.c7@tohoku.ac.jp

Recruiting

May. 21, 2025

Interventional

non-randomized controlled trial

open(masking not used)

historical control

factorial assignment

treatment purpose

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 femoral head necrosis by X-ray and MRI.

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

Both

Osteonecrosis of the femoral head

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 arthroscope is used as a bone marrow endoscope to confirm the state of the necrotic area.
Artificial bone is filled into the necrotic area, and the cortical and cancellous bones that were originally removed are replaced.
The amount of artificial bone to be filled depends on the size of the necrotic area.

Osteonecrosis of the femoral head, artificial bone

D005271

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.

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.

+81-22-718-0461

April. 30, 2025

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