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Recruitment status
Unique ID issued by UMIN UMIN000000988
Receipt No. R000000980
Scientific Title Comparative study of pronator quadratus preserved method and non-preserved method for distal radius fracture
Date of disclosure of the study information 2010/04/01
Last modified on 2008/01/21

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Basic information
Public title Comparative study of pronator quadratus preserved method and non-preserved method for distal radius fracture
Acronym Effect of pronator quadratus preserved operation for distal radius fracture in
Scientific Title Comparative study of pronator quadratus preserved method and non-preserved method for distal radius fracture
Scientific Title:Acronym Effect of pronator quadratus preserved operation for distal radius fracture in
Region
Japan

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

Objectives
Narrative objectives1 Examine the effect of pronator quadratus preserved method for distal radius fracture
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes bone union
function
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 pronator quadratus preserved method
Interventions/Control_2 pronator quadratus non-preserved method
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
100 years-old >
Gender Male and Female
Key inclusion criteria Patients who will undergo operation for distal radius fracture
Key exclusion criteria Patients who have physis
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasunori Kaneshiro
Organization Yodogawa Christian Hospital
Division name Department of Orthopaedic surgery
Zip code
Address 2-9-26, Awaji, Higashiyodogawa-ku, Osaka
TEL 06-6322-2250
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasunori Kaneshiro
Organization Yodogawa Christian Hospital
Division name Department of Orthopaedic surgery
Zip code
Address 2-9-26, Awaji, Higashiyodogawa-ku, Osaka
TEL
Homepage URL
Email

Sponsor
Institute Department of Orthopaedic surgery, Yodogawa Christian Hospital
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
Address
Tel
Email

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
2010 Year 04 Month 01 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
Date of protocol fixation
2007 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 05 Month 01 Day
Last follow-up date
2010 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
2008 Year 01 Month 21 Day
Last modified on
2008 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000980

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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