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

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 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


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

Value
https://center6.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