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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033207
Receipt No. R000037863
Scientific Title Biological characteristics of femoralintramedullary tissues obtained from patients undergoing autologous bone graft
Date of disclosure of the study information 2018/07/01
Last modified on 2018/06/29

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Basic information
Public title Biological characteristics of femoralintramedullary tissues obtained from patients undergoing autologous bone graft
Acronym Biological characteristics of femoralintramedullary tissues
Scientific Title Biological characteristics of femoralintramedullary tissues obtained from patients undergoing autologous bone graft
Scientific Title:Acronym Biological characteristics of femoralintramedullary tissues
Region
Japan

Condition
Condition fracture, nonunion, bone defect
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine biological characteristics of intramedullary tissues excavated and collected from patients who require autologous bone grafting by RIA system.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Investigation of biological characteristics of femoral intramedullary tissues
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 Patients who undergo autogenous bone grafting from the femur using the RIA system for the treatment of fractures, nonunions, bone defects
(1) The age at the time of consent acquisition is over 20 years.
(2) Document consent has been obtained from the subject person to this research.
Key exclusion criteria Patients who are judged inappropriate as the subject of this research by the research directors.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Niikura
Organization kobe University Graduate School of Medicine
Division name Department of Orthopaedic surgery
Zip code
Address 7-5-2, Kusunoki-Cho, Chuo-Ku, Kobe City, Hyogo,Japan
TEL 078-382-5985
Email tniikura@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Niikura
Organization Kobe University Graduate School of Medicine
Division name Department of Orthopaedic surgery
Zip code
Address 7-5-2, Kusunoki-Cho, Chuo-Ku, Kobe City, Hyogo,Japan
TEL 078-382-5985
Homepage URL
Email tniikura@med.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization Kobe University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 07 Month 01 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
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 Preinitiation
Date of protocol fixation
2018 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2018 Year 06 Month 29 Day
Last modified on
2018 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037863

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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