UMIN-CTR Clinical Trial

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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