UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025272
Receipt No. R000028911
Scientific Title Multicenter study for the efficacy and safety of DTN(distal tibia nail) in the trearment of fractures of the distal tibia.
Date of disclosure of the study information 2016/12/27
Last modified on 2018/12/19

* 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 Multicenter study for the efficacy and safety of DTN(distal tibia nail) in the trearment of fractures of the distal tibia.
Acronym Mulitcenter study for DTN(distai tibia nail).
Scientific Title Multicenter study for the efficacy and safety of DTN(distal tibia nail) in the trearment of fractures of the distal tibia.
Scientific Title:Acronym Mulitcenter study for DTN(distai tibia nail).
Region
Japan

Condition
Condition Distal tibia fracture
AO classification 43 type A1,A2,A3 and C1.
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We confirm the efficacy and safetiness of DTN in the clinical settings.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Efficacy : bone union rate at 6 months after surgery, median of bone union duration.

Safety : rate of adverse effect related to surgery(soft tissue injury, surgery procedure).
Key secondary outcomes All item below are assessed at surgery and 6, 12, 24, 52 week after surgery.

Clinical efficecy including QOL score : EQ-ED-5L Japanese edition, Self-Administered Foot Evaluation Questionnaire(SAFE-Q), AOFAS(The American Orthopedic Foot and Ankle Score)

Radiographical assessment : valgus and varus/anteversion and retroversion, rate of reduction loss/displacement.
Rate of adverse effect related to implant.
Visual analogue scale (VAS).
Surgery related assessment : operation time, X-ray exposure time.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.primary distal tibia fracture patient
(AO43 type A1, A2, A3 and C1).
2.Japanese people.
3.Age is over 18.
4.Patient who agree with this reserach by themselves or legal representative.
5.Patient who can visit hospital as plan.
6.Patient who can walk by themselves before fracture.
Key exclusion criteria 1.defromity of distal tibia
2.pathological fracture
3.allergy for metal
4.pregnant patient
5.two week past from injury
6.growth plate can be seen with X-ray photo
7.abuse of alchol or drug
8.patient who is judged as unqualified by reseracher.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoyuki Noda
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical science.
Division name Department of musculoskeletal traumatology (orthopedic)
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama prefecture.
TEL 086-235-7273
Email tnoda@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuaki Yamakawa
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical science.
Division name Department of Community Medicine
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama prefecture.
TEL 086-235-7273
Homepage URL
Email yamakawayasuaki@yahoo.co.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization Mizuho corporation
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 岡山大学病院(岡山県)
富山市立富山市民病院(富山県)
長崎大学病院(長崎県)
順天堂大学医学部附属静岡病院(静岡県)
福島県立医科大学(福島県)
独立行政法人国立病院機構 岡山医療センター(岡山県)
福山市民病院(広島県)
一般財団法人津山慈風会 津山中央病院(岡山県)
兵庫県立西宮病院(岡山県)
岡山赤十字病院(岡山県)

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 27 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 Enrolling by invitation
Date of protocol fixation
2016 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 27 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 09 Month 30 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information nothing

Management information
Registered date
2016 Year 12 Month 14 Day
Last modified on
2018 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028911

Research Plan
Registered date File name
2017/12/31 1.DTN研究実施計画書1.2版.docx

Research case data specifications
Registered date File name
2018/12/19 DTN症例報告書(1.1版).xlsx

Research case data
Registered date File name


Contact us.