Unique ID issued by UMIN | UMIN000003151 |
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Receipt number | R000003821 |
Scientific Title | Three-dimensional Kinematics during Deep Flexion Kneeling in Total Knee Arthroplasty : A prospective randomized study |
Date of disclosure of the study information | 2010/02/08 |
Last modified on | 2013/02/08 19:41:28 |
Three-dimensional Kinematics during Deep Flexion Kneeling in Total Knee Arthroplasty : A prospective randomized study
Three-dimensional Kinematics in Total Knee Arthroplasty
Three-dimensional Kinematics during Deep Flexion Kneeling in Total Knee Arthroplasty : A prospective randomized study
Three-dimensional Kinematics in Total Knee Arthroplasty
Japan |
Osteoarthritis of the knee
Orthopedics |
Others
NO
To measure the tibio-femoral kinematics and mobility of the PE mobile-bearing relative to the femoral and tibial components under weight-bearing conditions in a clinically representative cohort of patients implanted with rotating-platform mobile-bearing and fixed-bearing total knee arthroplasties
Efficacy
Exploratory
Pragmatic
Phase I
the tibio-femoral kinematics and mobility of the PE mobile-bearing relative to the femoral and tibial components under weight-bearing conditions
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Active
Numbered container method
2
Treatment
Device,equipment | Maneuver |
Fourty knees of 40 patients will be enrolled in this study based on our selection criteria. At the surgery, 20 knees out of them will be implanted the fixed-bearing ultrahighmolecular -weight PE insert, while the remaining 20 knees with the mobile -bearing one.
Fluoroscopic images will be taken at 12 months following surgery during kneel, squat, and stair-climb activities.
60 | years-old | <= |
Not applicable |
Male and Female
1) the diagnosis of osteoarthritis of the knee
2) the flexion angle of the knee more than 120 degrees
3)primary TKA
Patients who
1)have severe systemic diseases contraindicated for total knee arthroplasty
2)have revision surgery
40
1st name | |
Middle name | |
Last name | Hiroshi Mizuta |
Faculty of Life Sciences, Kumamoto University
Department of Orthopaedic and Neuro-Musculoskeletal Surgery
1-1-1, Honjyo, Kumamoto-City, Kumamoto
096-373-5226
1st name | |
Middle name | |
Last name | Eiichi Nakamura |
Kumamoto University Hospital
Department of Orthopaedic Surgery
1-1-1, Honjyo, Kumamoto-City, Kumamoto
096-373-5226
h@kumamoto-u.ac.jp
Department of Orthopaedic and Neuro-Musculoskeletal Surgery, Faculty of Life Sciences, Kumamoto University
Department of Orthopaedic and Neuro-Musculoskeletal Surgery, Faculty of Life Sciences, Kumamoto University
Other
NO
熊本大学医学部附属病院
2010 | Year | 02 | Month | 08 | Day |
Unpublished
Completed
2010 | Year | 02 | Month | 08 | Day |
2010 | Year | 02 | Month | 01 | Day |
2011 | Year | 12 | Month | 31 | Day |
2011 | Year | 12 | Month | 31 | Day |
2011 | Year | 12 | Month | 31 | Day |
2012 | Year | 08 | Month | 31 | Day |
2010 | Year | 02 | Month | 08 | Day |
2013 | Year | 02 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003821
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