UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A comparison of anterior and anterolateral approach in bilateral total hip arthroplasty
Title of the study (Brief title)	Anterior approaches for 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 clinical results after total hip arthroplasty between anterior and anterolateral approach in bilateral osteoarthritis of the hip
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Clinical and radiographical findings
Key secondary outcomes	Incidence of adverse events

Base
Study type

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Bilateral simultaneous total hip arthroplasty for bilateral osteoarthritis of the hip is performed. Anterior and anterolateral approaches are randomized to side.
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients receiving total hip arthroplasty for bilateral osteoarthritis of the hip.
Key exclusion criteria	Exclusion criteria of the patients are as follows. (1) Patients lacking ability to agree or ability to express agreement for participation appropriately in this study. (2) Severe contracture of the hip.
Target sample size	30

Research contact person
Name of lead principal investigator	Tetsuya Jinno
Organization	Tokyo Medical and Dental University
Division name	Department of Orthopaedic Surgery
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5279
Email	jinno.orth@tmd.ac.jp

Public contact
Name of contact person	Ryohei Takada
Organization	Tokyo Medical and Dental University
Division name	Department of Orthopaedic Surgery
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5279
Homepage URL
Email	takareh@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)

Secondary IDs
Secondary IDs	YES
Study ID_1	1797
Org. issuing International ID_1	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 06 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 02 Day
Anticipated trial start date	2014 Year 07 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 27 Day
Last modified on	2017 Year 12 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020973