UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035928
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

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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

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

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 or person

Institute

ORTHOREBIRTH CO. LTD.

Institute

Department

Personal name



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

Completed

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

2020 Year 08 Month 25 Day



Link to view the page

Value
https://center6.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