UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of conservative treatment for distal radius fractures.
Title of the study (Brief title)	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	Yuki Hara
Organization	University of Tsukuba
Division name	Faculty of medicine, department of orthopedic surgery
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	yuki Hara
Organization	University of Tsukuba
Division name	Faculty of medicine, department of orthopedic surgery
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 01 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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