Clinical trial of ORB-03 against bone defect
- Conditions
- Bone defect patients who need replacement with bone filling material
- Registration Number
- JPRN-UMIN000035928
- Lead Sponsor
- ORTHOREBIRTH CO. LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 59
Not provided
1. Patients who need bone filling material for multiple bone defects 2. Patients who need bone filling material for defects of the skull and vertebra 3. Patients who need press fit filling by bone filling material to bone defects 4. Patients with bone status following - Osteomyelitis - Having a history of severe osteomyelitis in bone defect - Having serious vascular disorder or neuropathy in bone defect - Having pathologic fractures excluding primary osteoporosis - Having an open fracture 5. Patients with systemic condition following - Maligant tumor - Severe blood disease - Severe Diabetes Mellitus - Requiring artificial dialysis therapy - Abnormal calcium metabolism - Bone target hormone metabolism abnormality - Immunodeficiency 6. Patients who have a history of allergy to the components of the clinical trial instrument 7. Patients who received steroids and steroid formulation-containing formulations within 3 months before filling trial instrument 8. Patients who underwent immunosuppressive therapy within 3 months before filling trial instrument 9. Pregnant women or women who want pregnancy during the trial period or lactating women 10. Patients who participated in other trials within one year before filling trial instrument 11. Other, patients who the investigator or subinvestigator doctor deemed inappropriate as subjects of this trial
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method