UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006772
Receipt number R000008010
Scientific Title Comparison of wear resistance,clinical result and radiological course between the cross-linked polyethylene-oxidized zirconium bearing couple and the cross-linked polyethylene-almina ceramic bearing couple in primary total hip arthroplasty. -A randomized controlled trial-
Date of disclosure of the study information 2011/11/25
Last modified on 2020/12/15 13:31:48

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Basic information

Public title

Comparison of wear resistance,clinical result and radiological course between the cross-linked polyethylene-oxidized zirconium bearing couple and the cross-linked polyethylene-almina ceramic bearing couple in primary total hip arthroplasty.
-A randomized controlled trial-

Acronym

Comparison of wear resistance between oxidized zirconium and almina ceramic.

Scientific Title

Comparison of wear resistance,clinical result and radiological course between the cross-linked polyethylene-oxidized zirconium bearing couple and the cross-linked polyethylene-almina ceramic bearing couple in primary total hip arthroplasty.
-A randomized controlled trial-

Scientific Title:Acronym

Comparison of wear resistance between oxidized zirconium and almina ceramic.

Region

Japan


Condition

Condition

Coxarthrosis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This Study aims to compare the linear wear, clinical result and radiological course between oxdized zirconium femoral head and almina ceramic femoral head articulated cross-linked polyethylene liner in primary total hip arthroplasty.

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Linear wear of the polyethylene liner(Dual circle technique)

Key secondary outcomes

Radiological course (wear,osteolysis,loosening)
Complication,adverse effect
Clinical result (Harris Hip Score,UCLA Score)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Oxinium femoral head 12/14

Interventions/Control_2

Ceramic ball head (almina ceramic)

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1)The patient indicated total hip arthroplasty owing to osteoarthritis of the hip joint secondary to developmental dysplasia of the hip joint.
2)The patient 75 aged or under.
3)The patient who can be inplanted 28mm diameter of the femoral head.
4)The patient whose UCLA score is 3 or more.

Key exclusion criteria

1)The patient indicated revision (total or partial) hip arthroplasty.
2)The patient who need the all polyethylene cup implantation.
3)The patient recognized not suitable for this study.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Kazuo
Middle name
Last name Hirakawa

Organization

Shonan Kamakura Joint Reconstruction Center

Division name

Department of Orthopaedic Surgery

Zip code

247-0061

Address

5-4-17 Dai,kamakura,Kanagawa

TEL

0467-47-2377

Email

mail@skjrc.jp


Public contact

Name of contact person

1st name Satoshi
Middle name
Last name Takayanagi

Organization

Shonan Kamakura Joint Reconstruction Center

Division name

Department of Orthopaedic Surgery

Zip code

247-0061

Address

5-4-17 Dai,kamakura,Kanagawa

TEL

0467-47-2377

Homepage URL


Email

mail@skjrc.jp


Sponsor or person

Institute

Shonan Kamakura Joint Reconstruction Center

Institute

Department

Personal name



Funding Source

Organization

Shonan Kamakura Joint Reconstruction Center

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Mirai Iryo Research Center

Address

1-8-7, Koji-machi, Chiyoda-ku, Tokyo 102-0083, Japan

Tel

03-3263-4801

Email

mirai-ec1@mirai-iryo.com


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



Other administrative information

Date of disclosure of the study information

2011 Year 11 Month 25 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

No longer recruiting

Date of protocol fixation

2011 Year 06 Month 29 Day

Date of IRB


Anticipated trial start date

2011 Year 11 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

2011 Year 11 Month 25 Day

Last modified on

2020 Year 12 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008010


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name