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Name:
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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011303
Receipt No. R000013209
Scientific Title A randomised controlled trial comparing bipolar hemiarthroplasty with total hip replacement for displaced intracapsular fractures of the femoral neck in active patients.
Date of disclosure of the study information 2013/10/01
Last modified on 2016/08/02

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Basic information
Public title A randomised controlled trial comparing bipolar hemiarthroplasty with total hip replacement for displaced intracapsular fractures of the femoral neck in active patients.
Acronym A Trial comparing bipolar hemiarthroplasty with total hip replacement intracapsular fractures of the femoral neck
Scientific Title A randomised controlled trial comparing bipolar hemiarthroplasty with total hip replacement for displaced intracapsular fractures of the femoral neck in active patients.
Scientific Title:Acronym A Trial comparing bipolar hemiarthroplasty with total hip replacement intracapsular fractures of the femoral neck
Region
Japan

Condition
Condition intracaplsular fractures of the femoral neck
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 THA is superior to BHA among activity intracapsule fracture of femoral neck.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Functional outcome(JOA score, walking ability), patient satisfaction(EQ-5D, JHEQ), radiographic evaluation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Total hip arthroplasty
Interventions/Control_2 Bipolar hemiarthroplasty
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
76 years-old >
Gender Male and Female
Key inclusion criteria 1.Displaced intracapsul fracture of femoral neck patients
2. THA or BHA performed by same surgical approaches
3. Age 20 years or older and 76 years younger
4. Femoral head size larger than 32mm
5. Walking independently without any orthosis
6. Informed consent
7. Possible to follow up surgery
Key exclusion criteria 1. History of infectious disease, previous hip surgery
2. BMI 40 over,
3. Pregnancy
4. History of neurological disease
5. History of Paget disease
6. History of steroid therapy and immunosuppression therapy
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukiharu HASEGAWA
Organization Nagoya university graduate school of medicine
Division name Department of Hip and Knee reconstructive surgery
Zip code
Address Tsumai-cho 65, Shouwa-ku, Nagoya-city, Aichi-prefecture, Japan
TEL +8152-744-1908
Email taekgami-toyomh@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhiko Takegami
Organization Nagoya university graduate school of medicine
Division name Department of Hip and Knee reconstructive surgery
Zip code
Address Tsumai-cho 65, Shouwa-ku, Nagoya-city, Aichi-prefecture, Japan
TEL +81-52-741-1908
Homepage URL
Email takegami-toyomh@umin.ac.jp

Sponsor
Institute Department of Hip and Knee reconstructive surgery,
Nagoya university graduate school of medicine
Institute
Department

Funding Source
Organization Stryker Japan KK, Yoshida orthopedic hospital, Naogya orthopedics joint replacement clinic
Organization
Division
Category of Funding Organization Profit 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 YES
Study ID_1 3937
Org. issuing International ID_1 Nagoya University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 名古屋大学医学部附属病院(愛知県)、名古屋医療センター(愛知県)、中津川市民病院(岐阜県)、吉田整形外科病院(愛知県)、浜松医療センター(静岡県)、中部ろうさい病院(愛知県)、岡崎市民病院(愛知県)、江南厚生病院(愛知県)

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 01 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
2013 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
2018 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 29 Day
Last modified on
2016 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013209

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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