UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study of frozen autograft bone treated by liquid nitrogen
Title of the study (Brief title)	Frozen bone graft treated by liquid nitrogen
Region	Japan

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

Objectives
Narrative objectives1	We have used liquid nitrogen treated autobone graft for reconstruction in case with bone defect following bone and soft tissue tumor resection surgery. Thought this method is consisted to be effective, the long term result is unidentified. This study is aimed for the accumulation of the further cases and follow-up more than five years.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Local control of tumor
Key secondary outcomes	Survival rate Limb function Bone union

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	autobone graft treated by liquid nitrogen, once at the time of surgery
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	0 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	The patient have consented to the study in the document. Case that has difficulty of skeletal reconstruction after tumor resection by conventional surgical method.
Key exclusion criteria	Case has difficulty in general anesthesia. Case dose not recover previous treatment for malignant tumor Case has uncontroled infection disease Case dose not have advantage with this method
Target sample size	20

Research contact person
Name of lead principal investigator	Yazawa Yasuo
Organization	Saitama Medical University International Medical Center
Division name	Orthopedic Oncology, Orthopedic Surgery
Address	1397-1 Yamane, Hidaka-City, Saitama, 350-1298 Japan
TEL	042-984-4111
Email	yyazawa@saitama-med.ac.jp

Public contact
Name of contact person	Torigoe Tomoaki
Organization	Saitama Medical University International Medical Center
Division name	Orthopedic Oncology, Orthopedic Surgery
Address	1397-1 Yamane, Hidaka-City, Saitama, 350-1298 Japan
TEL	042-984-4111
Homepage URL
Email	ttorigoe@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 04 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 12 Month 25 Day
Anticipated trial start date	2017 Year 01 Month 04 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	2016 Year 11 Month 16 Day
Last modified on	2016 Year 11 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028613