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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012650
Receipt No. R000014794
Official scientific title of the study 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

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Basic information
Official scientific title of the study In vivo kinematic analysis of total knee arthroplasty with 3-dimensional registration technique.
Title of the study (Brief title) 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Masashi Neo
Organization Osaka Medical College
Division name Dept. of orthopedic surgery
Address Daigakumachi 2-7, Takatsuki, OSAKA
TEL 072-683-1221
Email neo@poh.osaka-med.ac.jp

Public contact
Name of contact person Mikio Nakajima
Organization Osaka Medical College
Division name Dept. of orthopedic surgery
Address Daigakumachi 2-7, Takatsuki, OSAKA
TEL 072-683-1221
Homepage URL
Email ort054@poh.osaka-med.ac.jp

Sponsor
Institute Dept. of orthopedic surgery, Osaka Medical College
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2012 Year 01 Month 16 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014794


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