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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028757
Receipt No. R000032908
Scientific Title A comparison of hip stems with different proximal design (collared or collarless) in 1-stage total hip arthroplasty.
Date of disclosure of the study information 2017/09/30
Last modified on 2019/08/23

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Basic information
Public title A comparison of hip stems with different proximal design (collared or collarless) in 1-stage total hip arthroplasty.
Acronym A comparison of collared or collarless stem in total hip arthroplasty.
Scientific Title A comparison of hip stems with different proximal design (collared or collarless) in 1-stage total hip arthroplasty.
Scientific Title:Acronym A comparison of collared or collarless stem in total hip arthroplasty.
Region
Japan

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

Objectives
Narrative objectives1 To compare the results of bilateral simultaneous total hip arthroplasty between sides using stems with different design (collared or collarless).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Physical and radiographic findings at 3 and 6 months, 1, 3, 5, 10, 15, and 20 years postoperatively.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 A stem with different design is used for one side in bilateral simultaneous total hip arthroplasty.
Interventions/Control_2 A stem with different design is used for one side in bilateral simultaneous total hip arthroplasty.
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who will be performed bilateral total hip arthroplasty for hip disorders.
Key exclusion criteria 1) Hip implant is limited by the bone morphology.
2) Patients who will not agree to this study.
3) Patients who have severe complications intraoperatively or postoperatively.
4) Intraoperative change of the implants.
5) Patients lacking ability of self-assessment due to dementia etc.
6) Minor patients.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kazumasa
Middle name
Last name Miyatake
Organization Tokyo Medical and Dental University
Division name Department of Orthopaedics
Zip code 113-8519
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 0358034020
Email miyatake.orj@tmd.ac.jp

Public contact
Name of contact person
1st name Kazumasa
Middle name
Last name Miyatake
Organization Tokyo Medical and Dental University
Division name Department of Orthopaedics
Zip code 113-8510
Address Bunkyo-ku
TEL +81358034675
Homepage URL http://www.tmd.ac.jp/bioethics/11_4c561b7a9b3ed_4c563be18092b/index.html
Email miyatake.orj@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee, Faculty of Medicine, Tokyo Medical and Dental University
Address 1-5-45 Yushima
Tel 03-5803-5096
Email syomu1.adm@tmd.ac.jp

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 東京医科歯科大学医学部附属病院(東京都)
Tokyo Medical and Dental University Hospital of Medicine

Other administrative information
Date of disclosure of the study information
2017 Year 09 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 Enrolling by invitation
Date of protocol fixation
2017 Year 09 Month 01 Day
Date of IRB
2017 Year 11 Month 29 Day
Anticipated trial start date
2017 Year 11 Month 29 Day
Last follow-up date
2034 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 21 Day
Last modified on
2019 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032908

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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