UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024864 |
|---|---|
| Receipt number | 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 10:48:28 |
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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
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
ttorigoe@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028613
