UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043947 |
|---|---|
| Receipt number | R000050192 |
| Scientific Title | Image analysis study on the pathogenesis of hallux rigidus and hallux valgus |
| Date of disclosure of the study information | 2021/04/17 |
| Last modified on | 2022/10/20 03:24:30 |
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Basic information
Public title
Image analysis study on the pathogenesis of hallux rigidus and hallux valgus
Acronym
Image analysis study on the pathogenesis of hallux rigidus and hallux valgus
Scientific Title
Image analysis study on the pathogenesis of hallux rigidus and hallux valgus
Scientific Title:Acronym
Image analysis study on the pathogenesis of hallux rigidus and hallux valgus
Region
| Japan |
Condition
Condition
hallux rigidus , hallux valgus
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study compares the dynamics of the foot bones and joints in normal subjects and patients with hallux valgus and hallux valgus, and discusses the causes of these changes.
Basic objectives2
Others
Basic objectives -Others
In case of surgery, the patient will be reevaluated 6 months after the surgery.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparative study of foot bone and joint dynamics
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
CT scan
Interventions/Control_2
Dorsiflex the toes 30
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Normal group: Adults with no history of foot disease.
Key exclusion criteria
Normal group: Minors, those with a history of foot disease.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Kubota |
Organization
The Jikei University Katsushika Medical Center
Division name
Department of Orthopaedic Surgery
Zip code
125-8506
Address
6-41-2 Aoto, Katsushika-ku, Tokyo,, Japan
TEL
03-3603-2111
makoto.kubota@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Kihara |
Organization
The Jikei University School of Medicine
Division name
INSTITUTE FOR HIGH DIMENSIONAL MEDICAL IMAGING RESEARCH CENTER
Zip code
201-8601
Address
4-11-1, Wazumi-honmachi, Komae City, Tokyo
TEL
03-3480-1151
Homepage URL
takumi.kihara@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
nothing
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
The Jikei University School of Medicine
Address
3-25-8 Nishishinnbashi, Minato-ku, Tokyo, 105-8461, Japan
Tel
03-3433-1111
takumi.kihara@jikei.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 | 04 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 07 | 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
| 2021 | Year | 04 | Month | 16 | Day |
Last modified on
| 2022 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050192
