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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000011342
Receipt No. R000013292
Scientific Title Evaluation of the treatment for osteonecrosis of the femoral head
Date of disclosure of the study information 2013/08/01
Last modified on 2020/02/05

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Basic information
Public title Evaluation of the treatment for osteonecrosis of the femoral head
Acronym Evaluation of the treatment for osteonecrosis of the femoral head
Scientific Title Evaluation of the treatment for osteonecrosis of the femoral head
Scientific Title:Acronym Evaluation of the treatment for osteonecrosis of the femoral head
Region
Japan

Condition
Condition osteonecrosis of the femoral head
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the treatment of the osteonecrosis (THA or BHA),and investigate the differences of the clinical and radiographic parameters between THA and BHA
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes clinical evaluation(pre-operative,post-operative(6months,1year,2year))
Key secondary outcomes radiographic and functional evaluation,QOL of the patients,complication etc

Base
Study type

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Patients performed THA for the osteonecrosis
Interventions/Control_2 Patients performed BHA for the osteonecrosis
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
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients enable to perform THA and BHA ,with agreement of the study and follow up.
Key exclusion criteria The patients experienced past infection
or obesity(BMI>40)
or the patients who is pregnant
or the patients of neuromuscler/sensory nerve desease
or the patients with the history of disease that affects the entire body
or the inadequacy patients judged by the doctor
Target sample size 120

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 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-741-2111
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nagoya University Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL
Homepage URL
Email

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Stryker Japan
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
2013 Year 08 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
Not Registered
Results date posted
2020 Year 02 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Not Registered
Participant flow
Not Registered
Adverse events
Not Registered
Outcome measures
Not Registered
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2013 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
2016 Year 09 Month 30 Day
Date of closure to data entry
2018 Year 09 Month 30 Day
Date trial data considered complete
2018 Year 09 Month 30 Day
Date analysis concluded
2018 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 08 Month 01 Day
Last modified on
2020 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013292

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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