UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039189 |
|---|---|
| Receipt number | 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 18:07:07 |
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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
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
takahiro_inui@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044693
