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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035913
Receipt No. R000040916
Scientific Title Verification of the stem anteversion angle in THA during surgery
Date of disclosure of the study information 2019/02/18
Last modified on 2019/02/18

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Basic information
Public title Verification of the stem anteversion angle in THA during surgery
Acronym Verification of the stem anteversion angle in THA during surgery
Scientific Title Verification of the stem anteversion angle in THA during surgery
Scientific Title:Acronym Verification of the stem anteversion angle in THA during surgery
Region
Japan

Condition
Condition osteoarthritis of the hip
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of the stem anteversion angle in THA
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes calculate the angle of the stem anteversion in THA by post-op CT
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 verification of the mesuring instrument of the stem anteversion
Interventions/Control_2 the group without using the instrument
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
90 years-old >=
Gender Male and Female
Key inclusion criteria osteoarthritis of the hip
osteonecrosis of the hip
femoral neck fracture
Key exclusion criteria patients with internal medical problem
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Iwakiri
Organization Shiraniwa Hospital
Division name Orthopaedics
Zip code
Address 6-10-1 Shiraniwadai Ikoma-city
TEL 0743-70-0022
Email kenpiecekenpiece@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Iwakiri
Organization Shiraniwa Hospital
Division name Orthopaedics
Zip code
Address 6-10-1 Shiraniwadai Ikoma-city
TEL 0743-70-0022
Homepage URL
Email kenpiecekenpiece@yahoo.co.jp

Sponsor
Institute Shiraniwa Hospital
Institute
Department

Funding Source
Organization none
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
2019 Year 02 Month 18 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
2018 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 01 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
2019 Year 02 Month 18 Day
Last modified on
2019 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040916

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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