UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016806 |
|---|---|
| Receipt number | 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 12:46:04 |
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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
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
aharada@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics & Gerontology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019481
