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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012433
Receipt No. R000014526
Scientific Title Open-label clinical trial to evaluate the safety and efficacy of the investigational devices in total hip arthroplasty.
Date of disclosure of the study information 2013/12/01
Last modified on 2015/06/12

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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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