UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031199
Receipt number R000035568
Scientific Title Three dimensional motion analysis of the mobile medial-pivot type total knee arthroplasty
Date of disclosure of the study information 2018/03/01
Last modified on 2024/02/14 09:51:31

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Basic information

Public title

Three dimensional motion analysis of the mobile medial-pivot type total knee arthroplasty

Acronym

Three dimensional motion analysis of the mobile medial-pivot type total knee arthroplasty

Scientific Title

Three dimensional motion analysis of the mobile medial-pivot type total knee arthroplasty

Scientific Title:Acronym

Three dimensional motion analysis of the mobile medial-pivot type total knee arthroplasty

Region

Japan


Condition

Condition

osteoarthritis of the knee

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to analyze the postoperative knee motion for patients who underwent TKA with a mobile medial pivot type implant and to evaluate whether the knee motions are same as design concept that is like a normal knee.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Knee squatting motion at 6 months after surgery.
Evaluation parameter
:The amount of anteroposterior movement of the femur relative to the tibia
:Rotation angle of the femur relative to the tibia
:Motion pattern of the femur relative to the tibia
:Motion pattern of the insert

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

radiation exposure

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

varus osteoarthritis of the knee

Key exclusion criteria

valgus osteoarthritis of the knee
RA

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Osamu
Middle name
Last name Tanifuji

Organization

Niigata University Medical and Dental General Hospital

Division name

division of orthopedic surgery

Zip code

951-8510

Address

1-757, Asahimachidori, Chuoku, Niigata City, Niigata

TEL

025-227-2272

Email

tanifuji06242000@yahoo.co.jp


Public contact

Name of contact person

1st name Osamu
Middle name
Last name Tanifuji

Organization

Niigata University Medical and Dental General Hospital

Division name

division of orthopedic surgery

Zip code

951-8510

Address

1-757, Asahimachidori, Chuoku, Niigata City, Niigata

TEL

025-227-2272

Homepage URL


Email

tanifuji06242000@yahoo.co.jp


Sponsor or person

Institute

Niigata University Medical and Dental General Hospital

Institute

Department

Personal name



Funding Source

Organization

Niigata University Medical and Dental General Hospital

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

Niigata University Medical and Dental General Hospital

Address

1-757, Asahimachidori, Chuoku, Niigata City, Niigata

Tel

025-225-2625

Email

ethics@adm.niigata-u.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

2018 Year 03 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

10

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

Completed

Date of protocol fixation

2017 Year 12 Month 26 Day

Date of IRB

2018 Year 02 Month 19 Day

Anticipated trial start date

2018 Year 03 Month 01 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 02 Month 08 Day

Last modified on

2024 Year 02 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035568


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name