Clinical trial of ORB-03 against bone defect

Clinical trial of ORB-03 against bone defect - Clinical trial of ORB-03 against bone defect

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000035928

Enrollment

Registered

2019-02-19

Start date

2018-07-01

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

Bone defect patients who need replacement with bone filling material

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Consent Acquisition Age 20 years and over 2. Patients with bone loss due to traumatic injury (such as fracture), benign bone tumor removal and autogenous bone harvest 3. Patients with bone defect volume of 30 mL or less at one bone defect site 4. Patients who is stable in general condition and can perform surgery 5. Patients who can acquire informed consent from himself / herself

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Effective rate based on efficacy criteria at 24 weeks postoperative	—

Countries

Japan

Contacts

Public ContactShotaro Yabu

ORTHOREBIRTH CO. LTD. Production Engineering

yabu@orthorebirth.com045-532-3650

Outcome results