UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007298
Receipt number R000008322
Scientific Title Safety and Efficacy of Distal Targeting System with Open Reduction Internal Fixation: Multicenter Randomized Controlled Trial Study
Date of disclosure of the study information 2012/02/20
Last modified on 2021/07/08 11:47:18

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Basic information

Public title

Safety and Efficacy of Distal Targeting System with Open Reduction Internal Fixation: Multicenter Randomized Controlled Trial Study

Acronym

Safety and Efficacy of Distal Targeting System with ORIF: Multicenter RCT Study

Scientific Title

Safety and Efficacy of Distal Targeting System with Open Reduction Internal Fixation: Multicenter Randomized Controlled Trial Study

Scientific Title:Acronym

Safety and Efficacy of Distal Targeting System with ORIF: Multicenter RCT Study

Region

Japan


Condition

Condition

Fractures of tibia bone

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate the safety and efficacy of distal targeting system compared with conventional technique.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Presence or absence of adverse event

Key secondary outcomes

Reduced operative time
Reduced C-arm exposure time
Reduced C-arm exposure


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration

Institution is considered as a block.

Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Distal Targeting System TRIGEN SURESHOT

Interventions/Control_2

Conventional distal locking technique using C-arm

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patient whose written consent was obtained to participate in the study
2. Patient with indication for Intramedullary Nail

Key exclusion criteria

1. Patient with q pacemaker
2. Patient with metal implantation at tibia bone
3. Patient ruled unfit by surgeon

Target sample size

196


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiro Shirahama

Organization

Kurume University

Division name

Department of Orthopedic Surgery

Zip code


Address

67, Asahi-machi, Kurume-shi, Fukuoka-ken, Japan

TEL

0942-31-7568

Email

sirahama@med.kurume-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Junichi Oyama

Organization

Smith & Nephew Orthopaedics KK

Division name

Clinical Affairs & Ortho Specialties

Zip code


Address

Shiba Park Bldg. A-3F, 2-4-1, Shiba-Koen, Minato-ku, Tokyo, Japan

TEL

03-5403-8259

Homepage URL


Email

junichi.oyama@smith-nephew.com


Sponsor or person

Institute

Kurume University

Institute

Department

Personal name



Funding Source

Organization

Smith & Nephew Orthopaedics KK

Organization

Division

Category of Funding Organization

Profit organization

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

昭和大藤が丘病院(神奈川県)、順天堂大学静岡病院(静岡県)、仙台医療センター(宮城県)、新潟市民病院(新潟県)、久留米大学病院(福岡県)、慈恵医大葛飾医療センター(東京都)、済生会熊本病院(熊本県)、岡山赤十字病院(岡山県)、長崎大学病院(長崎県)、福島医科大学病院(福島県)、聖マリア病院(福岡県)


Other administrative information

Date of disclosure of the study information

2012 Year 02 Month 20 Day


Related information

URL releasing protocol


Publication of results

Published


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

Main results already published

Date of protocol fixation

2011 Year 08 Month 10 Day

Date of IRB


Anticipated trial start date

2011 Year 12 Month 16 Day

Last follow-up date

2014 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 02 Month 15 Day

Last modified on

2021 Year 07 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008322


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name