Unique ID issued by UMIN | UMIN000007298 |
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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 |
Safety and Efficacy of Distal Targeting System with Open Reduction Internal Fixation: Multicenter Randomized Controlled Trial Study
Safety and Efficacy of Distal Targeting System with ORIF: Multicenter RCT Study
Safety and Efficacy of Distal Targeting System with Open Reduction Internal Fixation: Multicenter Randomized Controlled Trial Study
Safety and Efficacy of Distal Targeting System with ORIF: Multicenter RCT Study
Japan |
Fractures of tibia bone
Orthopedics |
Others
NO
The purpose of this study is to evaluate the safety and efficacy of distal targeting system compared with conventional technique.
Safety,Efficacy
Presence or absence of adverse event
Reduced operative time
Reduced C-arm exposure time
Reduced C-arm exposure
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
Institution is considered as a block.
2
Treatment
Device,equipment |
Distal Targeting System TRIGEN SURESHOT
Conventional distal locking technique using C-arm
Not applicable |
Not applicable |
Male and Female
1. Patient whose written consent was obtained to participate in the study
2. Patient with indication for Intramedullary Nail
1. Patient with q pacemaker
2. Patient with metal implantation at tibia bone
3. Patient ruled unfit by surgeon
196
1st name | |
Middle name | |
Last name | Masahiro Shirahama |
Kurume University
Department of Orthopedic Surgery
67, Asahi-machi, Kurume-shi, Fukuoka-ken, Japan
0942-31-7568
sirahama@med.kurume-u.ac.jp
1st name | |
Middle name | |
Last name | Junichi Oyama |
Smith & Nephew Orthopaedics KK
Clinical Affairs & Ortho Specialties
Shiba Park Bldg. A-3F, 2-4-1, Shiba-Koen, Minato-ku, Tokyo, Japan
03-5403-8259
junichi.oyama@smith-nephew.com
Kurume University
Smith & Nephew Orthopaedics KK
Profit organization
NO
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)
2012 | Year | 02 | Month | 20 | Day |
Published
Main results already published
2011 | Year | 08 | Month | 10 | Day |
2011 | Year | 12 | Month | 16 | Day |
2014 | Year | 12 | Month | 31 | Day |
2012 | Year | 02 | Month | 15 | Day |
2021 | Year | 07 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008322
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