Unique ID issued by UMIN | UMIN000032537 |
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Receipt number | R000037107 |
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 | 2018/05/10 |
Last modified on | 2018/05/10 00:07:17 |
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 group 60 cases
Surgical maneuver of total knee arthroplasty
CR surface group 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 psterior cruciate ligament injury)
120
1st name | |
Middle name | |
Last name | Kazue Hayakawa |
Fujita health university school of medicine
Department of Orthopaedic Surgery
1-98 Dengakugakubo,Kutsukake-cho,Toyoake-city,Aichi,Japan
0562-93-2169
hkazue@fujita-hu.ac.jp
1st name | |
Middle name | |
Last name | Kazue Hayakawa |
Fujita health university school of medicine
Department of Orthoaedic Surgery
1-98 Dengakugakubo, kutsukake-cho,Toyoake-city,Aichi,japan
0562-93-2169
hkazue@fujita-hu.ac.jp
Fujita health university school of medicine
Fujita health university school of medicine
Self funding
NO
2018 | Year | 05 | Month | 10 | Day |
Unpublished
Enrolling by invitation
2018 | Year | 02 | Month | 22 | Day |
2018 | Year | 03 | Month | 28 | Day |
2018 | Year | 05 | Month | 10 | Day |
2018 | Year | 05 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037107
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