UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004382 |
|---|---|
| Receipt number | R000004988 |
| Scientific Title | Building a new system of eary prosthesis fitting using a new socket kit |
| Date of disclosure of the study information | 2010/10/15 |
| Last modified on | 2018/09/03 10:02:35 |
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Basic information
Public title
Building a new system of eary prosthesis fitting using a new socket kit
Acronym
Early Prosthesis fitting using a new socket kit
Scientific Title
Building a new system of eary prosthesis fitting using a new socket kit
Scientific Title:Acronym
Early Prosthesis fitting using a new socket kit
Region
| Japan |
Condition
Condition
tans-tibial amputation
Classification by specialty
| Endocrinology and Metabolism | Vascular surgery | Orthopedics |
| Plastic surgery | Emergency medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To show the effect of new socket kit.
Using the kit, we will be able to the lenth of stay of trans tibial amputee.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
length of stay from amputatio to discharge
Key secondary outcomes
legth of period from amutation to first prosthesis fitting
total cross section around stump
volume of stump
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
a new socket kit that makes possible imediate prosthesis fitting
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
| 10 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
trans-tibial amputee who make the first trans-tibial prosthesis at Yokohama City University Hospital, Deptertment of Rehabilitation Medicine
patiens who agrees to participate in the research
patients who has ability to walk with a prosthesis
Key exclusion criteria
patients who does not agree to participate
patients who has silicone allergy
patients who can not walk with a prostesis
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akinobu Nemoto |
Organization
Yokohama City University
Division name
School of medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2942
anemoto@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Hanada |
Organization
Yokohama CIty University Hospital
Division name
Dept. of Rehabilitation Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2713
Homepage URL
hanada.tk@gmail.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
横浜市立大学附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 14 | Day |
Last modified on
| 2018 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004988
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
