The clinical trial investigating the safety in the treatment of osteonecrosis of the femoral head with a local application of recombinant human bFGF gelatin hydrogel for bone regeneration and preventing the femoral head collapse.
- Conditions
- Osteonecrosis of the femoral head
- Registration Number
- JPRN-UMIN000009250
- Lead Sponsor
- Department of Orthopedic Surgery, Kyoto University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Not provided
Patients with Osteonecrosis of the femoral head who had been operated of the affected femoral head. BMI over 30. Serious complications including uncontrolled diabetes, serious hypertension, severe heart diseases and severe pulmonary diseases etc. Malignancies treated within 5 years not including carcinoma in situ and intramucosal carcinoma. Judged inappropriate with the reason for mental disorder or mental status by the treating physician Active infection Under treating diabetic retinopathy including preproliferative diabetic retinopathy and proliferative diabetic retinopathy. Gelatin allergy Drug allergy considered not to be suitable with this study. receiving systemic corticosteroids over 10mg dosage of Prednisolone.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Presence of adverse events
- Secondary Outcome Measures
Name Time Method Periodical assessment of clinical outcomes (VAS pain score, UCLA activity score, Harris Hip Score). Radiological assessment of the stage of osteonecrosis and the repaired femoral head using MRI.