UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Liquid nitrogen-treated autografts for bone and soft tissue tumors
Title of the study (Brief title)	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	Taketsugu Fujibuchi
Organization	Ehime University Graduate School of Medicine
Division name	Bone and Joint Surgery
Address	Shitsukawa, Toon city, Ehime pref.
TEL	+81-89-960-5343
Email	buchi@m.ehime-u.ac.jp

Public contact
Name of contact person	Taketsugu Fujibuchi
Organization	Ehime University Graduate School of Medicine
Division name	Bone and Joint Surgery
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 08 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000021741