UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003681 |
|---|---|
| Receipt number | R000004454 |
| Scientific Title | Multicenter follow-up study of a new artificial hip joint in which 2-methacryloyloxyethyl phosphorylcholine polymer is grafted onto the bearing surface of highly cross-linked ultrahigh molecular weight polyethylene liner |
| Date of disclosure of the study information | 2010/05/31 |
| Last modified on | 2014/12/01 10:15:22 |
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Basic information
Public title
Multicenter follow-up study of a new artificial hip joint in which 2-methacryloyloxyethyl phosphorylcholine polymer is grafted onto the bearing surface of highly cross-linked ultrahigh molecular weight polyethylene liner
Acronym
Multicenter follow-up study of a new artificial hip joint in which MPC polymer is grafted onto the bearing surface of highly cross-linked UHMWPE liner
Scientific Title
Multicenter follow-up study of a new artificial hip joint in which 2-methacryloyloxyethyl phosphorylcholine polymer is grafted onto the bearing surface of highly cross-linked ultrahigh molecular weight polyethylene liner
Scientific Title:Acronym
Multicenter follow-up study of a new artificial hip joint in which MPC polymer is grafted onto the bearing surface of highly cross-linked UHMWPE liner
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 evaluate the efficacy and safety of the investigational device, JMM-H01 to continuously examine the patients who participated in the previous clinical trial "Single arm and open-label multicenter clinical trial to evaluate the efficacy and safety of JMM-H01 in total hip arthroplasty (THA) in patients with hip joint disease".
(JMM-H01 is a MPC polymer treated highly cross-linked polyethylene liner.)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy
1) Survival rate of the investigational device, JMM-H01
2) Radiographic assessment
3) Clinical evaluation
-Evaluation chart of hip joint function (Japanese Orthopaedic Association, 1995)
-Merle d'Aubigne-Postel score
-QOL assessment (SF-36)
Safety
1) Adverse events
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with hip joint disease, who participated in the previous clinical trial using the investigational device, JMM-H01, and consented to this study in written form.
Key exclusion criteria
1) Patients whose JMM-H01 has been retrieved
2) Patients whom the investigator(s) judged not necessary for further investigation due to worsening of complications.
3) Patients whom the investigator(s) judged not necessary for further investigation due to inappropriateness to participate to this study.
Target sample size
80
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
Japan
Other related organizations
Co-sponsor
The University of Tokyo
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
東京大学医学部附属病院（東京都）、
埼玉医科大学病院（埼玉県）、
日本赤十字社医療センター（東京都）、
東日本電信電話株式会社 関東病院（東京都）、
東日本旅客鉄道株式会社 JR東京総合病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2010 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2010 | Year | 05 | Month | 31 | Day |
Last modified on
| 2014 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004454
| 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 |
