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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039189
Receipt No. R000044693
Scientific Title Dynamic analysis of ankle joint by four-dimensional CT
Date of disclosure of the study information 2020/04/01
Last modified on 2020/01/17

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Basic information
Public title Dynamic analysis of ankle joint by four-dimensional CT
Acronym Dynamic analysis of ankle joint by four-dimensional CT
Scientific Title Dynamic analysis of ankle joint by four-dimensional CT
Scientific Title:Acronym Dynamic analysis of ankle joint by four-dimensional CT
Region
Japan

Condition
Condition Normal ankle
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the motion of ankle joint
Basic objectives2 Others
Basic objectives -Others To evaluate the normal ankle joint
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Dynamic motion of syndesmosis
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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Four-dimensional CT
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
65 years-old >
Gender Male and Female
Key inclusion criteria 1) Aged equal to or more than 20 and less than 65 years old.
2) Agreement with informed consent.
Key exclusion criteria 1) Past history of the ankle, talus or calcaneus fractures.
2) With ankle osteoarthritis.
3) Past history of thoracoabdominal enhanced CT evaluation within 6 months.
4) Female who are pregnant or may be pregnant
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Yoshinobu
Middle name
Last name Watanabe
Organization Teikyo Uninversity School of Medicine
Division name Department of Orthopaedic Surgery
Zip code 1738606
Address 2-11-1 Kaga, Itabashi
TEL 0339641211
Email fracture@zad.att.ne.jp

Public contact
Name of contact person
1st name Takahiro
Middle name
Last name Inui
Organization Teikyo Uninversity School of Medicine
Division name Department of Orthopaedic Surgery
Zip code 1738606
Address 2-11-1 Kaga, Itabashi
TEL 0339641211
Homepage URL
Email takahiro_inui@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University
Institute
Department

Funding Source
Organization Bayer Yakuhin
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Department of Orthopaedic Surgery, Teikyo University School of Medicine
Address 2-11-1 Kaga, Itabashi, Tokyo
Tel 0339641211
Email fracture@zad.att.ne.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
2020 Year 04 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2020 Year 12 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
2020 Year 01 Month 17 Day
Last modified on
2020 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044693

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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