UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020985 |
|---|---|
| Receipt number | R000024218 |
| Scientific Title | Rotation of the first metatarsal in hallux valgus patients after surgical correction: A prospective longitudinal study. |
| Date of disclosure of the study information | 2016/02/12 |
| Last modified on | 2020/09/28 21:49:36 |
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Basic information
Public title
Rotation of the first metatarsal in hallux valgus patients after surgical correction: A prospective longitudinal study.
Acronym
Rotation of the first metatarsal in hallux valgus patients after surgical correction: A prospective longitudinal study.
Scientific Title
Rotation of the first metatarsal in hallux valgus patients after surgical correction: A prospective longitudinal study.
Scientific Title:Acronym
Rotation of the first metatarsal in hallux valgus patients after surgical correction: A prospective longitudinal study.
Region
| Japan |
Condition
Condition
Hallux valgus
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the change of the coronal plane rotation of the first metatarsal over time after hallux valgus surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Coronal plane rotation of the first metatarsal
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are to undergo hallux valgus surgery.
Key exclusion criteria
Patients with hallux valgus deformity due to chronic inflammatory disease such as rheumatoid arthritis.
Patients undergoing midfoot and/or hindfoot surgery such as second tarsometatarsal joint arthrodesis and surgeries for flatfoot.
Patients who are judged as inappropriate for the study by the physicians in charge.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Kanzaki |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery, Rehabilitation section
Zip code
6500017
Address
7-5-1 Kusunoki-Cho, Chuo-Ku, Kobe-City, Hyogo
TEL
078-382-5985
kanzaki@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuro |
| Middle name | |
| Last name | Yasui |
Organization
Teikyo University Mizonokuchi Hospital
Division name
Department of Orthopaedic Surgery
Zip code
2138507
Address
5-1-1 Futago, Takatsu-ku, Kawasaki, Kanagawa
TEL
044-844-3333
Homepage URL
yasuit@med.teikyo-u.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Kobe Graduate School of Medicine
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
IRB, Kobe University
Address
7-5-1 Kusunokicho Chuo-ku, Kobe, Japan
Tel
078-382-5111
kanzaki@med.kobe-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
神戸大学医学部附属病院(兵庫県)、千葉大学医学部附属病院(千葉県)、帝京大学医学部附属溝口病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 12 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All the patients who visited the clinic and fulfilled the inclusion criteria after February 2016.
Management information
Registered date
| 2016 | Year | 02 | Month | 12 | Day |
Last modified on
| 2020 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024218
