UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014126
Receipt number R000016450
Scientific Title Surgical Treatment for Distal Clavicle Fracture
Date of disclosure of the study information 2014/05/31
Last modified on 2017/06/02 13:33:21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Surgical Treatment for Distal Clavicle Fracture

Acronym

Surgical Treatment for Distal Clavicle Fracture

Scientific Title

Surgical Treatment for Distal Clavicle Fracture

Scientific Title:Acronym

Surgical Treatment for Distal Clavicle Fracture

Region

Japan


Condition

Condition

Distal clavicle fracture

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare with ligament reconstruction and plate fixation in the surgical treatment of the distal clavicle fracture

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Bony healing on X-ray, ROM, DASH score

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

ligament reconstruction

Interventions/Control_2

plate fixation

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


Not applicable

Gender

Male and Female

Key inclusion criteria

distal clavicle fracture indication for ORIF

Key exclusion criteria

previous surgery or dysfunction in the affected side

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Yamazaki

Organization

Aizawa Hospital

Division name

Department of Orthopaedic Surgery

Zip code


Address

1-5-2 Honjo, Matsumoto

TEL

0263-33-8600

Email

hiroshiymzk1017@ybb.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Yamazaki

Organization

Aizawa Hospital

Division name

Department of Orthopaedic Surgery

Zip code


Address

1-5-2 Honjo, Matsumoto

TEL

0263-33-8600

Homepage URL


Email

seke-dr5@ai-hosp.or.jp


Sponsor or person

Institute

Aizawa Hospital

Institute

Department

Personal name



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

2014 Year 05 Month 31 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

Open public recruiting

Date of protocol fixation

2011 Year 12 Month 23 Day

Date of IRB


Anticipated trial start date

2011 Year 12 Month 23 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

2014 Year 05 Month 31 Day

Last modified on

2017 Year 06 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016450


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name