UMIN-CTR Clinical Trial

Basic information
Public title	A comparison of hip stems with different length in total hip arthroplasty for moderate to severe hip disorders.
Acronym	A comparison of stems with different length in total hip arthroplasty.
Scientific Title	A comparison of hip stems with different length in total hip arthroplasty for moderate to severe hip disorders.
Scientific Title:Acronym	A comparison of stems with different length 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 length.
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.
Key secondary outcomes	Incidence of adverse events.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
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 length is used for one side in bilateral simultaneous total hip arthroplasty.
Interventions/Control_2	A stem with different length 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) Patients who are under age.
Target sample size	27

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 Orthopaedic Surgery
Zip code	113-8510
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5279
Email	miyatake.orj@tmd.ac.jp

Public contact
Name of contact person	1st name Masanobu Middle name Last name Hirao
Organization	Tokyo Medical and Dental University
Division name	Department of Orthopaedic Surgery
Zip code	113-8510
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5279
Homepage URL
Email	hirareh@tmd.ac.jp

Sponsor
Institute	Department of Orthopaedic Surgery, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	None
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, Bunkyo-ku, Tokyo
Tel	03-5803-5096
Email	syomu1.adm@tmd.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	1325
Org. issuing International ID_1	Ethics Committee, Faculty of Medicine, Tokyo Medical and Dental University
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	2015 Year 08 Month 05 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	30
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	No longer recruiting
Date of protocol fixation	2012 Year 09 Month 25 Day
Date of IRB	2012 Year 09 Month 25 Day
Anticipated trial start date	2012 Year 10 Month 23 Day
Last follow-up date	2032 Year 03 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	2015 Year 08 Month 05 Day
Last modified on	2022 Year 02 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021459