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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028700
Receipt No. R000032854
Scientific Title Changes in muscle strength of the hip and gait ability after rotational acetabular osteotomy: Retrospective study in a single institution.
Date of disclosure of the study information 2017/09/30
Last modified on 2017/12/26

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Basic information
Public title Changes in muscle strength of the hip and gait ability after rotational acetabular osteotomy: Retrospective study in a single institution.
Acronym Changes in muscle strength of the hip and gait ability after rotational acetabular osteotomy
Scientific Title Changes in muscle strength of the hip and gait ability after rotational acetabular osteotomy: Retrospective study in a single institution.
Scientific Title:Acronym Changes in muscle strength of the hip and gait ability after rotational acetabular osteotomy
Region
Japan

Condition
Condition Acetabular hip dysplasia
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the changes in muscle strength of the hip and gait ability after rotational acetabular osteotomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes At preoperation, postoperative 3-month, 6-month, and 1-year:
・Muscle strength of the hip
・Gait ability
Key secondary outcomes At preoperation, postoperative 3-month, 6-month, and 1-year:
・JOA score
・X-ray photograph, computed tomography

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients that an agreement of participating our study is provided in a document
Key exclusion criteria Patients who a study responsibility physician judged not to be eligible by other clear reasons. (e.g.patients who ware operated the opposite hip within this study's window, patients who has hemiplegia, patients who had deelayed union)
Patients that an agreement of participating our study is not provided in a document.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Enishi
Organization Tokushima Municipal Hospital
Division name Rehabilitation Medicine
Zip code
Address 2-34, Kitajosanjima, Tokushima, Tokushima, Japan. 7700812
TEL 088-622-5121
Email tetsuya-e@umin.org

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Enishi
Organization Tokushima Municipal Hospital
Division name Rehabilitation Medicine
Zip code
Address 2-34, Kitajosanjima, Tokushima, Tokushima, Japan. 7700812
TEL 088-622-5121
Homepage URL
Email tetsuya-e@umin.org

Sponsor
Institute Tokushima Municipal Hospital
Institute
Department

Funding Source
Organization Tokushima Municipal Hospital
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 2017-10
Org. issuing International ID_1 Tokushima Municipal Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 徳島市民病院(徳島県)

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 30 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 Enrolling by invitation
Date of protocol fixation
2017 Year 11 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 29 Day
Last follow-up date
Date of closure to data entry
2018 Year 01 Month 31 Day
Date trial data considered complete
2018 Year 01 Month 31 Day
Date analysis concluded
2018 Year 06 Month 30 Day

Other
Other related information not yet started

Management information
Registered date
2017 Year 08 Month 17 Day
Last modified on
2017 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032854

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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