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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000018802
Receipt No. R000021741
Scientific Title Liquid nitrogen-treated autografts for bone and soft tissue tumors
Date of disclosure of the study information 2015/08/25
Last modified on 2019/03/01

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Basic information
Public title Liquid nitrogen-treated autografts for bone and soft tissue tumors
Acronym Liquid nitrogen-treated autografts
Scientific Title Liquid nitrogen-treated autografts for bone and soft tissue tumors
Scientific Title:Acronym Liquid nitrogen-treated autografts
Region
Japan

Condition
Condition Primary bone and soft tissue tumor
Metastatic bone tumor
Classification by specialty
Orthopedics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study aimed to evaluate the safety and efficacy of liquid nitrogen-treated autografts for bone and soft tissue tumors
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes complication
the period required for bone union
functional outcome
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Liquid nitrogen-treated autograft
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The case judged that reconstruction by liquid nitrogen-treated autograft has more merit than artificial joint reconstruction
The case of bone and soft tissue tumor required to resection of bone
The case agreement is obtained in writing
Key exclusion criteria The case that autograft is impossible for destruction of bone
The case that has serious complication
(including heart disease, kidney disease, respiratory disease, hematological disease and diabetes mellitus)
The case that has uncontrollable infectious disease
WBC<2000/ul, Hb<7.0 g/dl, Plt.<50000/ul
The case that has difficulty in anesthesia
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taketsugu Fujibuchi
Organization Ehime University Graduate School of Medicine
Division name Bone and Joint Surgery
Zip code
Address Shitsukawa, Toon city, Ehime pref.
TEL +81-89-960-5343
Email buchi@m.ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taketsugu Fujibuchi
Organization Ehime University Graduate School of Medicine
Division name Bone and Joint Surgery
Zip code
Address Shitsukawa, Toon city, Ehime pref.
TEL +81-89-960-5343
Homepage URL
Email buchi@m.ehime-u.ac.jp

Sponsor
Institute Ehime University Graduate School of Medicine
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
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 愛媛大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 25 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 Terminated
Date of protocol fixation
2015 Year 08 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 25 Day
Last modified on
2019 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021741

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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