UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028444
Receipt number R000032561
Scientific Title In vivo polyethylene wear particle analysis after total knee arthroplasty
Date of disclosure of the study information 2019/01/01
Last modified on 2019/03/19 10:59:33

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Basic information

Public title

In vivo polyethylene wear particle analysis after total knee arthroplasty

Acronym

In vivo polyethylene wear particle analysis after total knee arthroplasty

Scientific Title

In vivo polyethylene wear particle analysis after total knee arthroplasty

Scientific Title:Acronym

In vivo polyethylene wear particle analysis after total knee arthroplasty

Region

Japan Asia(except Japan)


Condition

Condition

Osteoarthritis of the knee

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the PE wear particles from TKAs using Oxidized zirconium and TKAs with Cobalt-chromium alloy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Number, size, and shape of PE wear particles

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

20 years-old <

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with TKA

Key exclusion criteria

Patinets without TKA

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Yukihide
Middle name
Last name Minoda

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Orthopaedic Surgery

Zip code

5458585

Address

1-4-3, Asahimachi, Abeno-ku, Osaka

TEL

06-6645-3851

Email

yminoda@msic.med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name Yukihide
Middle name
Last name Minoda

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Orthopaedic Surgery

Zip code

5458585

Address

1-4-3, Asahimachi, Abeno-ku, Osaka

TEL

06-6645-3851

Homepage URL


Email

yminoda@msic.med.osaka-cu.ac.jp


Sponsor or person

Institute

Osaka City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Osaka City University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka City University Graduate School of Medicine

Address

1-5-7, Asahimachi, Abeno-ku, Osaka

Tel

06-6645-3456

Email

hiro-nishi@med.osaka-cu.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



Other administrative information

Date of disclosure of the study information

2019 Year 01 Month 01 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

0

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

Terminated

Date of protocol fixation

2016 Year 12 Month 12 Day

Date of IRB

2017 Year 01 Month 30 Day

Anticipated trial start date

2017 Year 08 Month 01 Day

Last follow-up date

2019 Year 03 Month 19 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2017 Year 07 Month 30 Day

Last modified on

2019 Year 03 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032561


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name