Unique ID issued by UMIN | UMIN000035928 |
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Receipt number | R000040927 |
Scientific Title | Clinical trial of ORB-03 against bone defect |
Date of disclosure of the study information | 2019/02/19 |
Last modified on | 2020/08/25 15:42:41 |
Clinical trial of ORB-03 against bone defect
Clinical trial of ORB-03 against bone defect
Clinical trial of ORB-03 against bone defect
Clinical trial of ORB-03 against bone defect
Japan |
Bone defect patients who need replacement with bone filling material
Orthopedics |
Others
NO
The objective is to evaluate the effectiveness and safety of ORB - 03 against bone defects and to examine the operability at the time of filling
Safety,Efficacy
Effective rate based on efficacy criteria at 24 weeks postoperative
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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
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
54
1st name | Masashi |
Middle name | |
Last name | Makita |
ORTHOREBIRTH CO. LTD.
Production Engineering
904-2234
Okinawa Life Science Research Center No.123, 5-8, Suzaki, Uruma-City, Okinawa, 904-2234 Japan
098-989-7250
makita@orthorebirth.com
1st name | Shotaro |
Middle name | |
Last name | Yabu |
ORTHOREBIRTH CO. LTD.
Production Engineering
224-0032
15-3-303 Chigasaki-Chuo, Tsuzuki-ku, Yokohama, Kanagawa, Japan 224-0032
045-532-3650
yabu@orthorebirth.com
ORTHOREBIRTH CO. LTD.
None
Self funding
ORTHOREBIRTH Co., Ltd. Ethics Review Committee
15-3-303 Chigasaki-Chuo, Tsuzuki-ku, Yokohama, Kanagawa, Japan 224-0032
045-532-3650
yamada@orthorebirth.com
NO
2019 | Year | 02 | Month | 19 | Day |
Unpublished
59
Completed
2018 | Year | 04 | Month | 18 | Day |
2018 | Year | 03 | Month | 23 | Day |
2018 | Year | 07 | Month | 01 | Day |
2020 | Year | 01 | Month | 24 | Day |
None
2019 | Year | 02 | Month | 19 | Day |
2020 | Year | 08 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040927
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