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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024214
Receipt No. R000027884
Scientific Title Influence of wrist position in the cast immobilization for treatment of the distal radius fracture
Date of disclosure of the study information 2016/09/29
Last modified on 2020/04/02

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Basic information
Public title Influence of wrist position in the cast immobilization for treatment of the distal radius fracture
Acronym Influence of wrist position in the cast immobilization for treatment of the distal radius fracture
Scientific Title Influence of wrist position in the cast immobilization for treatment of the distal radius fracture
Scientific Title:Acronym Influence of wrist position in the cast immobilization for treatment of the distal radius fracture
Region
Japan

Condition
Condition distal radius fracture
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of wrist position in the cast immobilization for treatment of the distal radius fracture
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Volar tilt
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 casting in dorsiflexion
Interventions/Control_2 casting in palmarflexion
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient treated with the cast immobilization in distal radius fracture
Key exclusion criteria patient with open fracture, can not be taken the consent, epiphyseal line , multiple trauma
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Yamazaki
Organization Aizawa hospital
Division name Department of Orthopedic Surgery
Zip code 390-8510
Address 1-5-2 Honjo, Matsumoto
TEL 0263-33-8600
Email hiroshiymzk1017@ybb.ne.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Yamazaki
Organization Aizawa hospital
Division name Department of Orthopedic Surgery
Zip code 390-8510
Address 1-5-2 Honjo, Matsumoto
TEL 0263-33-8600
Homepage URL
Email hiroshiymzk1017@ybb.ne.jp

Sponsor
Institute Aizawa hospital
Institute
Department

Funding Source
Organization Aizawa hospital
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 Aizawa hospital
Address 1-5-2 Honjo, Matsumoto
Tel 0263-33-8600
Email hiroshiymzk1017@ybb.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
2016 Year 09 Month 29 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 Completed
Date of protocol fixation
2016 Year 09 Month 28 Day
Date of IRB
2016 Year 09 Month 29 Day
Anticipated trial start date
2016 Year 09 Month 29 Day
Last follow-up date
2020 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 29 Day
Last modified on
2020 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027884

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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