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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025655
Receipt No. R000028455
Scientific Title Prospective study of conservative treatment for distal radius fractures.
Date of disclosure of the study information 2017/02/01
Last modified on 2017/01/12

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Basic information
Public title Prospective study of conservative treatment for distal radius fractures.
Acronym Prospective study of conservative treatment for distal radius fractures.
Scientific Title Prospective study of conservative treatment for distal radius fractures.
Scientific Title:Acronym Prospective study of conservative treatment for distal radius fractures.
Region
Japan

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

Objectives
Narrative objectives1 The objective of this study is to clarify the efficacy of conservative treatment for distal radius fractures under unified protocol.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome of this study is the change in X-ray parameters of the distal radius (volar tilt, radial inclination, ulnar variance) from between the time of injury to just after the closed reduction; a week , two weeks, three weeks and six weeks after the reduction; 3 months, 6 months and a year after the reduction.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 The conservative treatment for distal radius fractures under unified protocol will be performed. The protocol consists of at least 10 minutes traction using Chinese finger trap, closed reduction and above elbow fixation using sugar tong splint.
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 The inclusion criteria is those patients who diagnosed as distal radius fracture by X-ray, and considered appropriate for conservative treatment.
Key exclusion criteria The exclusion criteria are follows;
1. Those who cannot make an agreement spontaneously.
2. Those who are unable to make an agreement under written document.
3. Those who did not need any reduction and treated using under elbow fixation.
4. Those who cannot treat conservatively using splint fixation due to compartment syndrome or other similar situations.
5. Those who injured bilateral distal radius at the same time, or those who has disability on unaffected side such as paralysis.
6. Those who has medical history of distal radius fractures.
7. Those who has medical history of any disease involving bone deformity such as rheumatoid arthritis.
8. Those who considered as surgical indication at the first visit.
9. Those who considered not appropriate for the study by the doctors.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuki Hara
Organization University of Tsukuba
Division name Faculty of medicine, department of orthopedic surgery
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575
TEL 029-853-3219
Email yukihara@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name yuki Hara
Organization University of Tsukuba
Division name Faculty of medicine, department of orthopedic surgery
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575
TEL 029-853-3219
Homepage URL
Email yukihara@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Self funding
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
2017 Year 02 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 Preinitiation
Date of protocol fixation
2017 Year 01 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 12 Day
Last modified on
2017 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028455

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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