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 |
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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
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
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
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
