Unique ID issued by UMIN | UMIN000029187 |
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Receipt number | R000031962 |
Scientific Title | Open-label, non-controlled study of new intramedullary guide for total knee arthroplasty (TKA), linked with 3D surgical support software. |
Date of disclosure of the study information | 2017/09/19 |
Last modified on | 2018/11/21 16:31:29 |
Open-label, non-controlled study of new intramedullary guide for total knee arthroplasty (TKA), linked with 3D surgical support software.
Study of new intramedullary guide for TKA, linked with 3D surgical support software.
Open-label, non-controlled study of new intramedullary guide for total knee arthroplasty (TKA), linked with 3D surgical support software.
Study of new intramedullary guide for TKA, linked with 3D surgical support software.
Japan |
Patients with knee joint disease who are scheduled to undergo total knee arthroplasty (osteoarthritis, rheumatoid arthritis, knee osteonecrosis).
Orthopedics |
Others
NO
To assess the efficacy and safety of total knee arthroplasty using new intramedullary guide, linked with 3D surgical support software in patients with knee joint disease.
Safety,Efficacy
Difference between 3D pre-operative planning and post-operative implantation (by tibial component, internal and external rotation).
Difference between 3D pre-operative planning and post-operative implantation (by other than tibial component, internal and external rotation).
Adverse event.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Using new intramedullary guide linked with 3D surgical support software for total knee arthroplasty
20 | years-old | <= |
Not applicable |
Male and Female
(1)Patients with knee joint disease (osteoarthritis, rheumatoid arthritis, knee osteonecrosis).
(2)Patients who are scheduled to undergo total knee arthroplasty.
(3)Age more than 20 years, at the time of acquiring consent.
(4)Document consent can be obtained by the patient's free will, after receiving sufficient explanation for the participation of this study, after understanding.
(1)Patients judged by the principal investigator to be inappropriate as subjects.
(2)Patients who have been registered in this study in the past.
(3)Patients with or suspected to have Creutzfeldt-Jakob disease.
20
1st name | |
Middle name | |
Last name | Daihei Kida |
National Hospital Organization Nagoya Medical Center
Orthopedic Surgery and Rheumatology
4-1-1 Sannomaru, Naka-ku, Nagoya-shi, Aichi, 460-0001, Japan
052-951-1111
kidad@nnh.hosp.go.jp
1st name | |
Middle name | |
Last name | Daihei Kida |
National Hospital Organization Nagoya Medical Center
Orthopedic Surgery and Rheumatology
4-1-1 Sannomaru, Naka-ku, Nagoya-shi, Aichi, 460-0001, Japan
052-951-1111
kidad@nnh.hosp.go.jp
National Hospital Organization Nagoya Medical Center
National Hospital Organization Nagoya Medical Center
Self funding
NO
独立行政法人 国立病院機構 名古屋医療センター
2017 | Year | 09 | Month | 19 | Day |
Unpublished
Completed
2017 | Year | 08 | Month | 25 | Day |
2017 | Year | 09 | Month | 19 | Day |
2017 | Year | 09 | Month | 19 | Day |
2018 | Year | 11 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031962
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