UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019523 |
|---|---|
| Receipt number | R000022579 |
| Scientific Title | Prospective study for treatment of femoral intertrochanteric fracture-ORIF VS bipolar prosthesis |
| Date of disclosure of the study information | 2015/10/27 |
| Last modified on | 2015/11/02 23:33:19 |
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Basic information
Public title
Prospective study for treatment of femoral intertrochanteric fracture-ORIF VS bipolar prosthesis
Acronym
Prospective study for treatment of femoral intertrochanteric fracture
Scientific Title
Prospective study for treatment of femoral intertrochanteric fracture-ORIF VS bipolar prosthesis
Scientific Title:Acronym
Prospective study for treatment of femoral intertrochanteric fracture
Region
| Japan |
Condition
Condition
patients of femoral intertrochanteric fracture
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare muscle strength around hip joint
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To compare muscle strength using evaluating machine between half and one year postoperatively
Key secondary outcomes
To conduct function evaluation using Barthel index for walking or stair climbing
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Open reduction and internal fixation
Interventions/Control_2
Bipolar hip prosthesis
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
| 80 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
more than half year postoperative followup
Key exclusion criteria
bilateral cases
deceased
severe dimentia
neurological impairement
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuaki Noda |
Organization
Konan hospital
Division name
orthopedics
Zip code
Address
Kobe higasinadaku kamokogahara 1-5-16
TEL
078-851-2161
m-noda@muf.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuaki Noda |
Organization
Konan hospital
Division name
orthopedics
Zip code
Address
Kobe higasinadaku kamokogahara 1-5-16
TEL
078-851-2161
Homepage URL
m-noda@muf.biglobe.ne.jp
Sponsor or person
Institute
Mitsuaki Noda
Institute
Department
Personal name
Funding Source
Organization
Mitsuaki Noda
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
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 | 10 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 15 | 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 | 10 | Month | 27 | Day |
Last modified on
| 2015 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022579
