UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025272 |
|---|---|
| Receipt number | 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 | 2023/02/10 18:14:32 |
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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 | Tomoyuki |
| Middle name | |
| Last name | Noda |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical science.
Division name
Department of musculoskeletal traumatology (orthopedic)
Zip code
7008558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama prefecture.
TEL
086-235-7273
tnoda@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuaki |
| Middle name | |
| Last name | Yamakawa |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical science.
Division name
Department of Community Medicine
Zip code
7008558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama prefecture.
TEL
086-235-7273
Homepage URL
yamakawayasuaki@yahoo.co.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
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
Center for clinicla innovative medicine
Address
2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama prefecture.
Tel
086-235-6504
ouh-csnw@adm.okayama-u.ac.jp
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
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
12
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
1 year extension of enrolled period
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
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 16 | Day |
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
| 2023 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.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 |
