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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000026612
Receipt No. R000030566
Scientific Title functional recovery for displaced femoral neck fracture after reduction
Date of disclosure of the study information 2018/06/30
Last modified on 2017/03/20

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Basic information
Public title functional recovery for displaced femoral neck fracture after reduction
Acronym functional recover for displaced femoral neck fracture
Scientific Title functional recovery for displaced femoral neck fracture after reduction
Scientific Title:Acronym functional recover for displaced femoral neck fracture
Region
Japan

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

Objectives
Narrative objectives1 Compare muscular strength, radiographic assessement, and function between operative and non-operative side.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes better muscular strength compared to contralateral side
Postoperative follow-up requires at least 6months and one year or more.
Key secondary outcomes radiographic finding will be satisfactory probably due to less non-union, osteonecrosis of femoral head.
Radiographic evaluation can be conducted after 3months at earliest.

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 during the operative procedure
we reduce displaced fragment under control of image intensifier.
When displacement can be successfully reduced, internal fixation was applied.
Interventions/Control_2 no reduction of the fragment
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
100 years-old >=
Gender Male and Female
Key inclusion criteria displaced femoral neck fracture
Key exclusion criteria combined
Osteoarthritis,
bilateral fracture
severe dimentia
CNS and peripheral nerve trouble
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name noda mitsuaki
Organization Konan hospital
Division name orthopedic department
Zip code
Address Kobe, higasinada, kamokogahara1-5-16
TEL 81-78-851-2161
Email m-noda@muf.biglobe.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name noda mitsuaki
Organization Konan hospital
Division name orthopedic department
Zip code
Address Kobe, higasinada, kamokogahara1-5-16
TEL 81-78-851-2161
Homepage URL
Email m-noda@muf.biglobe.ne.jp

Sponsor
Institute No payment accepted.
Institute
Department

Funding Source
Organization Same s above
Organization
Division
Category of Funding Organization Other
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
2018 Year 06 Month 30 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
Date of protocol fixation
2016 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 20 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
2017 Year 03 Month 20 Day
Last modified on
2017 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030566

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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