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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016806
Receipt No. R000019481
Scientific Title Development of reinforcement surgery for the unaffected femur in proximal femoral fracture
Date of disclosure of the study information 2015/03/17
Last modified on 2015/03/16

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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


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