UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052844 |
|---|---|
| Receipt number | R000060301 |
| Scientific Title | Relevance of conventional and objective assessment of soft tissue for the transfemoral amputees. |
| Date of disclosure of the study information | 2023/11/21 |
| Last modified on | 2023/11/19 20:37:58 |
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Basic information
Public title
Relevance of conventional and objective assessment of soft tissue for the transfemoral amputees.
Acronym
Relevance of conventional and objective assessment of soft tissue for the transfemoral amputees.
Scientific Title
Relevance of conventional and objective assessment of soft tissue for the transfemoral amputees.
Scientific Title:Acronym
Relevance of conventional and objective assessment of soft tissue for the transfemoral amputees.
Region
| Japan |
Condition
Condition
femoral amputation
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the relationship between conventional "evaluation" and "objective evaluation" in the evaluation of soft tissue at the time of femoral prosthesis socket fabrication. At the same time, to compare the values of the "objective evaluation" between femoral amputees and male students, and to help in the creation of femoral prosthetic sockets.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
･Soft Tissue Evaluation of Broken Ends
Conventional evaluation using VAS (evaluation by prosthetist)
Quantitative evaluation using ultrasound imaging system (evaluation by principal investigator)
･Evaluation of the length of the transected end
Conventional evaluation using VAS (evaluation by prosthetist)
Quantitative evaluation using a femoral prosthesis disc gauge (evaluation by principal investigator)
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
The duration of the intervention is one day and the number of interventions is one day. The flexibility will be measured using a diagnostic ultrasound device.
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Femoral amputees. The study will be conducted on those who understand the content of the study and agree to participate in it. The healthy subjects will be those who understand the content of the study and agree to participate in it.
Key exclusion criteria
Subjects will be excluded from the study if they are unable to give consent to participate in the study.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | kazuto |
| Middle name | |
| Last name | kamiwaki |
Organization
Niigata University of Health and Welfare
Division name
Major in Medical and Rehabilitation Sciences
Zip code
950-3102
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata Prefecture
TEL
070-2816-2169
ham22001@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | kazuto |
| Middle name | |
| Last name | kamiwaki |
Organization
Niigata University of Health and Welfare
Division name
Major in Medical and Rehabilitation Sciences
Zip code
950-3102
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata Prefecture
TEL
070-2816-2169
Homepage URL
ham22001@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata Prefecture
Tel
070-2816-2169
ham22001@nuhw.ac.jp
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
| 2023 | Year | 11 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 19 | Day |
Last modified on
| 2023 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060301
