UMIN-CTR Clinical Trial

Basic information
Public title	Open-label clinical trial to evaluate the safety and efficacy of the investigational devices in total hip arthroplasty.
Acronym	Open-label clinical trial to evaluate the safety and efficacy of the investigational devices in total hip arthroplasty.
Scientific Title	Open-label clinical trial to evaluate the safety and efficacy of the investigational devices in total hip arthroplasty.
Scientific Title:Acronym	Open-label clinical trial to evaluate the safety and efficacy of the investigational devices in total hip arthroplasty.
Region	Japan

Condition
Condition	Patients with hip joint disease caused by hip osteoarthritis and others.
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We confirm the functional equivalency of the investigational devices to the approved artificial hip joint as well as absence of serious adverse device effects in clinical trial.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Japanese orthopedic association hip score Serious adverse device effect
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	-
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with an indication for THA who are selected by orthopedic specialist of the JOA and consented to the operation. 2) Inpatients or outpatients with a written first-person consent. 3) Patients aged 20 and over. (Not gender specific)
Key exclusion criteria	The exclusion criteria having effects on the evaluation of the investigational devices. 1) Patients who had or will have THA or BHA in the opposite hip within 6 months before or after the operation in this clinical trial. 2) Patients who previously had THA or BHA in the opposite hip and it is apparent that prosthesis exhibits loosening. 3) Patients who are difficult to be followed for 6 months after the surgery. 4) Patients who participated clinical trial of another investigational device or drug within 6 months before participating to this clinical trial. 5) Patients who once participated this clinical trial. 6) Patients in unstable clinical conditions or fatal condition. 7) Patients who have clinically serious organ derangement. *Additionally, there are exclusion criteria related to the product characteristics of the investigational devices.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroko Tanioka
Organization	KYOCERA Medical Corporation
Division name	Regulatory Affairs Development Dept. Research and Development Corporate Division
Zip code
Address	3-3-31 Miyahara, Yodogawa-Ku, Osaka, 532-0003 Japan
TEL	06-6350-1493
Email	hiroko.tanioka@kyocera-md.jp

Public contact
Name of contact person	1st name Middle name Last name Kiyoyasu fujii
Organization	KYOCERA Medical Corporation
Division name	Regulatory Affairs Development Dept. Research and Development Corporate Division
Zip code
Address	3-3-31 Miyahara, Yodogawa-Ku, Osaka, 532-0003 Japan
TEL	06-6350-1493
Homepage URL
Email	kiyoyasu.fujii@kyocera-md.jp

Sponsor
Institute	KYOCERA Medical Corporation
Institute
Department

Funding Source
Organization	KYOCERA Medical Corporation
Organization
Division
Category of Funding Organization	Profit organization
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	佐賀大学医学部附属病院（佐賀県）

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 01 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	Completed
Date of protocol fixation	2013 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date	2013 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	2013 Year 11 Month 28 Day
Last modified on	2015 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014526

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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