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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024864
Receipt No. R000028613
Scientific Title Clinical study of frozen autograft bone treated by liquid nitrogen
Date of disclosure of the study information 2017/01/04
Last modified on 2016/11/21

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Basic information
Public title Clinical study of frozen autograft bone treated by liquid nitrogen
Acronym Frozen bone graft treated by liquid nitrogen
Scientific Title Clinical study of frozen autograft bone treated by liquid nitrogen
Scientific Title:Acronym 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
1st name
Middle name
Last name Yazawa Yasuo
Organization Saitama Medical University International Medical Center
Division name Orthopedic Oncology, Orthopedic Surgery
Zip code
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
1st name
Middle name
Last name Torigoe Tomoaki
Organization Saitama Medical University International Medical Center
Division name Orthopedic Oncology, Orthopedic Surgery
Zip code
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)

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
2017 Year 01 Month 04 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
2016 Year 12 Month 25 Day
Date of IRB
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

Other
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

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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