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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014160
Receipt No. R000016486
Scientific Title Multicenter long-term 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 2014/06/04
Last modified on 2020/02/26

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Basic information
Public title Multicenter long-term 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 long-term 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 long-term 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 long-term 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

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 and Postel score
-QOL assessment (SF-36)

Safety
1) Adverse events and device deficiency
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 77

Research contact person
Name of lead principal investigator
1st name Hiroko
Middle name
Last name Tanioka
Organization KYOCERA Corporation
Division name Senior Manager Regulatory Affairs & Clinical Development Dept. Medical Division
Zip code 520-2362
Address 800 Ichimiyake, Yasu, Shiga, Japan
TEL 077-507-3395
Email hiroko.tanioka.ke@kyocera.jp

Public contact
Name of contact person
1st name Kiyoyasu
Middle name
Last name Fujii
Organization KYOCERA Corporation
Division name Clinical Development Section Regulatory Affairs & Clinical Development Dept. Medical Division
Zip code 520-2362
Address 800 Ichimiyake, Yasu, Shiga, Japan
TEL 077-507-3395
Homepage URL
Email kiyoyasu.fujii.sd@kyocera.jp

Sponsor
Institute KYOCERA Corporation
Institute
Department

Funding Source
Organization KYOCERA 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 Graduate School of Medicine and Faculty of Medicine, The University of Tokyo,Intervention Research Ethics Committee
Address 7-3-1,Hongo,Bunkyo-ku,Tokyo
Tel 03-5841-0818
Email ethics@m.u-tokyo.ac.jp

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)、
NTT東日本関東病院(東京都)、
JR東京総合病院(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 04 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 69
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 No longer recruiting
Date of protocol fixation
2014 Year 04 Month 28 Day
Date of IRB
2014 Year 05 Month 22 Day
Anticipated trial start date
2014 Year 06 Month 16 Day
Last follow-up date
2023 Year 10 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2014 Year 06 Month 04 Day
Last modified on
2020 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016486

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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