UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014160
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

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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 Yuka
Middle name
Last name Yamanashi

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

yuka.yamanashi.zs@kyocera.jp


Sponsor or person

Institute

KYOCERA Corporation

Institute

Department

Personal name



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

Research Ethics Committee, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo

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

2022 Year 12 Month 26 Day



Link to view the page

Value
https://center6.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