UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012650
Receipt number R000014794
Scientific Title In vivo kinematic analysis of total knee arthroplasty with 3-dimensional registration technique.
Date of disclosure of the study information 2013/12/21
Last modified on 2013/12/21 12:27:22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

In vivo kinematic analysis of total knee arthroplasty with 3-dimensional registration technique.

Acronym

Kinematic analysis of total knee arthroplasty.

Scientific Title

In vivo kinematic analysis of total knee arthroplasty with 3-dimensional registration technique.

Scientific Title:Acronym

Kinematic analysis of total knee arthroplasty.

Region

Japan


Condition

Condition

osteoarthritis or rheumatoid arthritis of the knee joint

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the in vivo kinematics of total knee arthroplasty in weight-bearing,
deep knee bending motion

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

3D kinematic analysis dada: fluoroscopc digital x-ray images using 2D/3D registration technique in weight-bearing, deep knee bending at 1 yaer arter total knee arthroplasty

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

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Fluoroscopy was performed to continuously
capture the knee from the lateral direction in a weight-bearing
position and knee bending position.

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

A patient unederwent toal knee arthloplasty with osteoarthritis or rheumatoid arthritis of knee joint.

Key exclusion criteria

none

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masashi Neo

Organization

Osaka Medical College

Division name

Dept. of orthopedic surgery

Zip code


Address

Daigakumachi 2-7, Takatsuki, OSAKA

TEL

072-683-1221

Email

neo@poh.osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mikio Nakajima

Organization

Osaka Medical College

Division name

Dept. of orthopedic surgery

Zip code


Address

Daigakumachi 2-7, Takatsuki, OSAKA

TEL

072-683-1221

Homepage URL


Email

ort054@poh.osaka-med.ac.jp


Sponsor or person

Institute

Dept. of orthopedic surgery, Osaka Medical College

Institute

Department

Personal name



Funding Source

Organization

Dept. of orthopedic surgery, Osaka Medical College

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


Address


Tel


Email



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

2013 Year 12 Month 21 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

Enrolling by invitation

Date of protocol fixation

2012 Year 01 Month 16 Day

Date of IRB


Anticipated trial start date

2014 Year 12 Month 31 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

2013 Year 12 Month 21 Day

Last modified on

2013 Year 12 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014794


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name