UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019748 |
|---|---|
| Receipt number | R000022809 |
| Scientific Title | Diagnostic usefulness of the "Weber nose" in evaluation of fibular length at ankle joint. Proposal of a novel radiographic measurement of the ankle and investigation of its utility using X-rays of healthy volunteers. |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2020/11/19 11:53:40 |
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Basic information
Public title
Diagnostic usefulness of the "Weber nose" in evaluation of fibular length at ankle joint.
Proposal of a novel radiographic measurement of the ankle and investigation of its utility using X-rays of healthy volunteers.
Acronym
Usefulness of the Weber nose in evaluation of fibular length.
Scientific Title
Diagnostic usefulness of the "Weber nose" in evaluation of fibular length at ankle joint.
Proposal of a novel radiographic measurement of the ankle and investigation of its utility using X-rays of healthy volunteers.
Scientific Title:Acronym
Usefulness of the Weber nose in evaluation of fibular length.
Region
| Japan |
Condition
Condition
Ankle fractures
Classification by specialty
| Orthopedics | Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To propose a novel radiographic measurement showing relationship between the spike of the medial cortex of the lateral malleolus (Weber nose) and the tibial plafond.
And to determine its normal value and reliability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The normal value of a novel radiographic measurement showing relationship between the Weber nose and the tibial plafond.
Key secondary outcomes
Inter- and intraobserver reliability of the measurement.
Difference between right and left ankles.
Correlation with age, sex,talocrural angle, and length of lateral malleolus (an existing measurement).
Difference between non-weight bearing and weight bearing conditions.
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Right and left ankle X-rays (mortise view) are taken in non-weight bearing and weight bearing conditions. Three observers measure the following three measurements (one of the observers measures twice at least two weeks apart).
A. Talocrural angle.
B. Length of lateral malleolus.
C. A distance between the line tangent to the tibial plafond and the tip of the Weber nose (this is defined as "fibular variance, FV").
D. A value obtained by dividing the value of C by the distance between the tibial plafond and the upper aspect of the talus (this is defined as "fibular variance index, FVI").
The following are evaluated; the normal value of FV and FVI, their inter- and intraobserver reliability, the difference between the right and left ankle, the difference between non-weight bearing and weight bearing conditions, and the correlations with the talocrural angle, length of lateral malleolus, age, and sex.
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers, 20 males and 20 females.
Key exclusion criteria
Those with a history of ankle injury or disease.
(Possible) pregnant females.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Kurata |
Organization
Sapporo Tokushukai Hospital
Division name
Division of Orthopaedic Trauma
Zip code
004-0041
Address
1-1 Ohyachi Higashi 1, Atsubetsu Sapporo, Hokkaido 004-0041
TEL
011-890-1110
ykurata@h5.dion.ne.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Kurata |
Organization
Sapporo Tokushukai Hospital
Division name
Division of Orthopaedic Trauma
Zip code
004-0041
Address
1-1 Ohyachi Higashi 1, Atsubetsu Sapporo, Hokkaido 004-0041
TEL
011-890-1110
Homepage URL
ykurata@h5.dion.ne.jp
Sponsor or person
Institute
Division of Orthopaedic Trauma
Sapporo Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Tokushukai Hospital Group IRB
Address
1-8-7 Kojimachi, Chiyoda, Tokyo
Tel
03-3263-4801
machida@mirai-iryo.com
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
札幌徳洲会病院（北海道）
Sapporo Tokushukai Hospital (Hokkaido)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 01 | 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
Main results already published
Date of protocol fixation
| 2015 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 21 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 07 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 11 | Day |
Last modified on
| 2020 | 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=R000022809
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