Unique ID issued by UMIN | UMIN000043422 |
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Receipt number | R000049577 |
Scientific Title | A randomized, prospective, comparative study of cemented and cementless total knee arthroplasty using the Persona trabecular metal tibial component |
Date of disclosure of the study information | 2021/02/23 |
Last modified on | 2021/02/23 16:42:04 |
A randomized, prospective, comparative study of cemented and cementless total knee arthroplasty using the Persona trabecular metal tibial component
Randomized, prospective, comparative study of the Persona trabecular metal tibial component with or without cement
A randomized, prospective, comparative study of cemented and cementless total knee arthroplasty using the Persona trabecular metal tibial component
Randomized, prospective, comparative study of the Persona trabecular metal tibial component with or without cement
Japan |
To evaluate whether the initial fixation force is increased if bone cement is applied only to the tray part of the Persona TM tibial component
Orthopedics |
Others
NO
To evaluate whether the initial fixation force is increased if bone cement is applied only to the tray part of the Persona TM tibial component
Efficacy
Changes in bone near the peg by plain X-ray
Changes in bone density near the tibial peg over time
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Maneuver |
Standard cementless total knee arthroplasty
cemented TKA
50 | years-old | <= |
100 | years-old | >= |
Male and Female
Patients giving voluntary written informed consent to participate in the study
Patients aged 50 years or older
Patients undergoing initial TKA
Osteoarthritis (OA), rheumatoid arthritis (RA), idiopathic osteonecrosis of the medial femoral condyle
Patients who cannot attend postoperative follow-up at Months 1, 3, 6, and Year 1
Patients not suitable for Persona TM tibia (large bone defect, ligament imbalance, damage to posterior cruciate ligament, revision TKA)
Patients whom the investigator/sub-investigator consider unsuitable for this study
100
1st name | Kazue |
Middle name | |
Last name | Hayakawa |
Fujita health university school of medicine
Orthopedicas
4701192
1-98 Dengakugakubo Kutsukakecho Toyoake City
+81562932169
hkazue@fujita-hu.ac.jp
1st name | Kaszue |
Middle name | |
Last name | Hayakawa |
Fujita health university school of medicine
Orthopedics
4701192
1-98 Dengakugakubo Kutsukakecho Toyoake City
+81562932169
hkazue@fujita-hu.ac.jp
Fujita health university school of medicine
Fujita health university school of medicine
Self funding
Fujita health university
1- 98 Dengakugakubo Kutuskakecho
+81562932169
hkazue@fujita-hu.ac.jp
NO
2021 | Year | 02 | Month | 23 | Day |
Unpublished
Enrolling by invitation
2021 | Year | 02 | Month | 23 | Day |
2020 | Year | 12 | Month | 21 | Day |
2021 | Year | 03 | Month | 03 | Day |
2025 | Year | 07 | Month | 31 | Day |
2021 | Year | 02 | Month | 23 | Day |
2021 | Year | 02 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049577
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