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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020985
Receipt No. 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

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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
Email 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
Email yasuit@med.teikyo-u.ac.jp

Sponsor
Institute Department of Orthopaedic Surgery, Kobe Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024218

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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