UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045436 |
|---|---|
| Receipt number | R000048894 |
| Scientific Title | Simple measurement of the hindfoot alignment with the whole leg standing radiography |
| Date of disclosure of the study information | 2021/09/15 |
| Last modified on | 2022/03/19 07:11:21 |
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Basic information
Public title
Simple measurement of the hindfoot alignment with the whole leg standing radiography
Acronym
Simple measurement of the hindfoot alignment with the whole leg standing radiography
Scientific Title
Simple measurement of the hindfoot alignment with the whole leg standing radiography
Scientific Title:Acronym
Simple measurement of the hindfoot alignment with the whole leg standing radiography
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish a simple method to assess the hindfoot alignment from the whole lower extremity X-ray images of healthy subjects.
Basic objectives2
Others
Basic objectives -Others
To measure the normal value of hindfoot alignment in whole lower extremity X-ray images of healthy subjects.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intra- and inter-examiner reliability of hindfoot alignment in the whole leg standing radiograph (the angle formed by the line connecting the tibial shaft and the center of the talus to the ground contact point of the calcaneus)
Key secondary outcomes
The normal value of hindfoot alignment in the whole leg standing radiograph (the angle formed by the line connecting the tibial shaft and the center of the talus to the ground contact point of the calcaneus)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Applicants must have no pain or other symptoms in the lower limbs (hip, knee, ankle, or foot) and no previous surgery for fracture or ligament injury.
Key exclusion criteria
Those with a BMI of 30 or more, flat feet or concave feet, general joint laxity, and those who are pregnant or may become pregnant
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Eto |
Organization
Saga university hospital
Division name
Department of Orthopedic surgery
Zip code
8498501
Address
5-1-1 Nabeshima, Saga city, Saga, Japan.
TEL
0952342343
shu.1.uhs0306@gmail.com
Public contact
Name of contact person
| 1st name | Shuichi |
| Middle name | |
| Last name | Eto |
Organization
Saga university hospital
Division name
Department of Orthopedic surgery
Zip code
8498501
Address
5-1-1 Nabeshima, Saga city, Saga, Japan.
TEL
0952342343
Homepage URL
sagaseikei@gmail.com
Sponsor or person
Institute
Department of Orthopedic Surgery, Saga university hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopedic Surgery, Saga university hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical research center, Saga university hospital
Address
5-1-1 Nabeshima, Saga city, Saga, Japan.
Tel
0952-34-3400
kenkyu-shinsei@ml.cc.saga-u.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
| 2021 | Year | 09 | 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
40
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
Main results already published
Date of protocol fixation
| 2019 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
X-ray images are taken to measure the lower extremity alignment.
Management information
Registered date
| 2021 | Year | 09 | Month | 09 | Day |
Last modified on
| 2022 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048894
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
