UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025655 |
|---|---|
| Receipt number | 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 23:01:18 |
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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
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
yukihara@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028455
