Unique ID issued by UMIN | UMIN000014160 |
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Receipt number | 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 | 2022/12/26 16:47:47 |
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
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
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
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
Japan |
Patients with hip joint disease caused by hip osteoarthritis and others
Orthopedics |
Others
NO
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.)
Safety,Efficacy
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
Observational
Not applicable |
Not applicable |
Male and Female
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.
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.
77
1st name | Hiroko |
Middle name | |
Last name | Tanioka |
KYOCERA Corporation
Senior Manager Regulatory Affairs & Clinical Development Dept. Medical Division
520-2362
800 Ichimiyake, Yasu, Shiga, Japan
077-507-3395
hiroko.tanioka.ke@kyocera.jp
1st name | Yuka |
Middle name | |
Last name | Yamanashi |
KYOCERA Corporation
Clinical Development Section Regulatory Affairs & Clinical Development Dept. Medical Division
520-2362
800 Ichimiyake, Yasu, Shiga, Japan
077-507-3395
yuka.yamanashi.zs@kyocera.jp
KYOCERA Corporation
KYOCERA Corporation
Profit organization
Research Ethics Committee, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
7-3-1,Hongo,Bunkyo-ku,Tokyo
03-5841-0818
ethics@m.u-tokyo.ac.jp
NO
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)
2014 | Year | 06 | Month | 04 | Day |
Unpublished
69
No longer recruiting
2014 | Year | 04 | Month | 28 | Day |
2014 | Year | 05 | Month | 22 | Day |
2014 | Year | 06 | Month | 16 | Day |
2023 | Year | 10 | Month | 22 | Day |
None
2014 | Year | 06 | Month | 04 | Day |
2022 | Year | 12 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016486
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