UMIN-CTR Clinical Trial

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
Email	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
Email	kenhiraga@yahoo.co.jp

Sponsor
Institute	Miyukikai Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042844