UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037796 |
|---|---|
| Receipt number | R000042844 |
| Scientific Title | lateral end embedding and dynamic fixation with long nail for unstable intertrochanteric femur fracture |
| Date of disclosure of the study information | 2019/08/27 |
| Last modified on | 2021/03/05 16:58:31 |
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Basic information
Public title
lateral end embedding and dynamic fixation with long nail for unstable intertrochanteric femur fracture
Acronym
lateral end embedding and dynamic fixation with long nail for unstable intertrochanteric femur fracture
Scientific Title
lateral end embedding and dynamic fixation with long nail for unstable intertrochanteric femur fracture
Scientific Title:Acronym
lateral end embedding and dynamic fixation with long nail for unstable intertrochanteric femur fracture
Region
| Japan |
Condition
Condition
unstable interotrochanteric femur fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to decrease complication, unstable intertrochanteric femur fractures are fixed with secure dynamization of the distal fragment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
complication from 1 to 2 years postoperatively
Key secondary outcomes
mobilisation capacity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Unstable intertrochanteric femur fracture are fixed with secure axial compression. We use the long cephallomedullary nail, embed the lateral end of the lag screw, lock the lag screw to the nail and insert the distal screw to the dynamized position.
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
unstable intertrochanteric femur fracture
Key exclusion criteria
pathological fracture
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Hiragami |
Organization
Miyukikai Hospital
Division name
medical office
Zip code
999-3161
Address
2-2-11 Benten, Kaminoyama, Yamagata
TEL
+81-23-672-8282
kenhiraga@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Hiragami |
Organization
Miyukikai Hospital
Division name
medical office
Zip code
999-3161
Address
2-2-11 Benten, Kaminoyama, Yamagata
TEL
023-672-8282
Homepage URL
kenhiraga@yahoo.co.jp
Sponsor or person
Institute
Miyukikai Hospital
Institute
Department
Personal name
Funding Source
Organization
Miyukikai Hospital
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
Miyukikai Hospital ethics comittie
Address
2-2-11 Benten, Kaminoyama, Yamagata
Tel
023-672-8282
kenhiraga@yahoo.co.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2019 | Year | 08 | Month | 26 | Day |
Last modified on
| 2021 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042844
