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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035928
Receipt No. R000040927
Scientific Title Clinical trial of ORB-03 against bone defect
Date of disclosure of the study information 2019/02/19
Last modified on 2019/08/29

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Basic information
Public title Clinical trial of ORB-03 against bone defect
Acronym Clinical trial of ORB-03 against bone defect
Scientific Title Clinical trial of ORB-03 against bone defect
Scientific Title:Acronym Clinical trial of ORB-03 against bone defect
Region
Japan

Condition
Condition Bone defect patients who need replacement with bone filling material
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Effective rate based on efficacy criteria at 24 weeks postoperative
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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
Key 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
Target sample size 54

Research contact person
Name of lead principal investigator
1st name Masashi
Middle name
Last name Makita
Organization ORTHOREBIRTH CO. LTD.
Division name Production Engineering Department
Zip code 904-2234
Address Okinawa Life Science Research Center No.123, 5-8, Suzaki, Uruma-City, Okinawa, 904-2234 Japan
TEL 098-989-7250
Email makita@orthorebirth.com

Public contact
Name of contact person
1st name Shotaro
Middle name
Last name Yabu
Organization ORTHOREBIRTH CO. LTD.
Division name Production Engineering Department
Zip code 224-0032
Address 15-3-303 Chigasaki-Chuo, Tsuzuki-ku, Yokohama, Kanagawa, Japan 224-0032
TEL 045-532-3650
Homepage URL
Email yabu@orthorebirth.com

Sponsor
Institute ORTHOREBIRTH CO. LTD.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization ORTHOREBIRTH Co., Ltd. Ethics Review Committee
Address 15-3-303 Chigasaki-Chuo, Tsuzuki-ku, Yokohama, Kanagawa, Japan 224-0032
Tel 045-532-3650
Email yamada@orthorebirth.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 19 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 59
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 04 Month 18 Day
Date of IRB
2018 Year 03 Month 23 Day
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
2020 Year 01 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2019 Year 02 Month 19 Day
Last modified on
2019 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040927

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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