Unique ID issued by UMIN | UMIN000038577 |
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Receipt number | R000037106 |
Scientific Title | Prospective randomized two-group comparative clinical study of patient satisfaction after total knee arthroplasty using Persona articular surface implants |
Date of disclosure of the study information | 2019/11/14 |
Last modified on | 2019/11/14 00:08:16 |
Prospective randomized two-group comparative clinical study of patient satisfaction after total knee arthroplasty using Persona articular surface implants
Randomized two-group comparison of Persona articular surface implants
Prospective randomized two-group comparative clinical study of patient satisfaction after total knee arthroplasty using Persona articular surface implants
Randomized two-group comparison of Persona articular surface implants
Japan |
Osteoarthritis, Rhumatoid Arthritis, Osteonecrosis
Orthopedics |
Others
NO
This study will compare the level of patient satisfaction after CR-type TKA with ACL resection in the Persona MC surface (test) group and the conventional Persona CR surface (control) group, between which the only difference is the Persona surface implant used, to determine which knee prosthesis is associated with greater patient satisfaction.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Plain X-ray findings and clinical evaluation at one year after TKA.
Plain X-ray findings and clinical evaluation at 6 months after TKA.
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Maneuver |
Surgical maneuver of total knee arthroplasty
MC surface(test) 60 cases
Surgical maneuver of total knee arthroplasty
CR surface(control) 60 cases
55 | years-old | <= |
Not applicable |
Male and Female
the case that adapted to total knee arthroplasty
the case who obtained consent by document
Patients attending physician has determined ineligible
example posterior cruciate ligament injury
120
1st name | Kazue |
Middle name | |
Last name | Hayakawa |
Fujita health university school of medicine
Department of Orthopaedic Surgery
4701192
1-98 Dengakugakubo,Kutsukake-cho,Toyoake-city,Aichi,Japan
0562932169
hkazue@fujita-hu.ac.jp
1st name | Kazue |
Middle name | |
Last name | Hayakawa |
Fujita health university school of medicine
Department of Orthoaedic Surgery
4701192
1-98 Dengakugakubo, kutsukake-cho,Toyoake-city,Aichi,japan
0562932169
hkazue@fujita-hu.ac.jp
Fujita health university school of medicine
Self funding
Self funding
Fujita Health University
1-98 Dengakugakubo Kutsukake cho Toyoake city Aichi
0562932169
hkazue@fujita-hu.ac.jp
NO
2019 | Year | 11 | Month | 14 | Day |
Unpublished
Enrolling by invitation
2018 | Year | 02 | Month | 22 | Day |
2018 | Year | 02 | Month | 08 | Day |
2018 | Year | 03 | Month | 28 | Day |
2021 | Year | 12 | Month | 31 | Day |
2019 | Year | 11 | Month | 14 | Day |
2019 | Year | 11 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037106
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