UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002197 |
|---|---|
| Receipt number | R000002702 |
| Scientific Title | allograft from the cadaver for the bone defect after bone tumor excision |
| Date of disclosure of the study information | 2009/08/31 |
| Last modified on | 2013/01/22 13:24:22 |
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Basic information
Public title
allograft from the cadaver for the bone defect after bone tumor excision
Acronym
allograft from the cadaver
Scientific Title
allograft from the cadaver for the bone defect after bone tumor excision
Scientific Title:Acronym
allograft from the cadaver
Region
| Japan |
Condition
Condition
giant cell tumor of the bone
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
treatment of pelvic bone tumor
Basic objectives2
Others
Basic objectives -Others
massive bone defect after bone tumor excision will be treated with allograft from cadaver
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
evaluation of grafted bone union with X-p, CT and MRI
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
A medical manual skill
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
| 29 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Female
Key inclusion criteria
a female case only
Key exclusion criteria
nothing
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Mizuta |
Organization
Kumamoto University
Division name
Department of orthopaedic surgery
Zip code
Address
1-1-1 Honjo, kumamoto
TEL
096-373-5226
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroo Sato |
Organization
Kumamoto University
Division name
Department of orthopaedic surgery
Zip code
Address
TEL
096-373-5226
Homepage URL
Sponsor or person
Institute
Department of orthopaedic surgery, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
nothing
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
| 2009 | Year | 08 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 14 | Day |
Last modified on
| 2013 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002702
