UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000032908