UMIN-CTR Clinical Trial

Basic information
Public title	Development of reinforcement surgery for the unaffected femur in proximal femoral fracture
Acronym	Reinforcement surgery for the unaffected femur
Scientific Title	Development of reinforcement surgery for the unaffected femur in proximal femoral fracture
Scientific Title:Acronym	Reinforcement surgery for the unaffected femur
Region	Japan

Condition
Condition	Proximal femoral fracture
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify whether screw reinforcement surgery for the unaffected proximal femur is effective in reducing its risk of fracture.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Risk of fracture in the unaffected proximal femur
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Screw insertion to reinforce the unaffected proximal femur in the intervention group.
Interventions/Control_2	No intervention for the unaffected proximal femur in the control group.
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients aged 65 years or older with proximal femoral fractures 2) Patients in whom osteosynthesis surgery was selected for the treatment of fracture 3) Informed consent by patients or their family for participation in the study
Key exclusion criteria	1) Patients with bilateral proximal femoral fractures 2) Patients in whom femoral head prosthetic replacement was selected 3) A history of any hip surgery on the unaffected side 4) A history of severe joint destruction or infection in the unaffected hip joint 5) Patients with a high risk of infection 6) Patients in whom any stress other than fracture surgery should be avoided because of severe complications 7) Patients determined by their attending physicians to be inappropriate as subjects in the present study for other reasons
Target sample size	180

Research contact person
Name of lead principal investigator	1st name Middle name Last name Atsushi Harada
Organization	National Center for Geriatrics & Gerontology
Division name	Department of Orthopedic Surgery
Zip code
Address	7-430, Morioka-machi, Obu, Aichi, Japan
TEL	+81-562-46-2311
Email	aharada@ncgg.go.jp

Public contact
Name of contact person	1st name Middle name Last name Atsushi Harada
Organization	National Center for Geriatrics & Gerontology
Division name	Department of Orthopedic Surgery
Zip code
Address	7-430, Morioka-machi, Obu, Aichi, Japan
TEL	+81-562-46-2311
Homepage URL
Email	aharada@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics & Gerontology
Institute
Department

Funding Source
Organization	The Research Funding for Longevity Sciences from National Center for Geriatrics & Gerontology
Organization
Division
Category of Funding 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

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 17 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	Open public recruiting
Date of protocol fixation	2014 Year 07 Month 04 Day
Date of IRB
Anticipated trial start date	2014 Year 12 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 03 Month 16 Day
Last modified on	2015 Year 03 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019481

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.