UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012433 |
|---|---|
| Receipt number | 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 16:22:44 |
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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
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
kiyoyasu.fujii@kyocera-md.jp
Sponsor or person
Institute
KYOCERA Medical Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014526
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
