Unique ID issued by UMIN | UMIN000005334 |
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Receipt number | R000006340 |
Scientific Title | The Outcome of the NexGen CR-Flex Mobile Bearing Knee Prosthesis:A multi centre non comparative prospective study |
Date of disclosure of the study information | 2011/03/28 |
Last modified on | 2023/10/09 13:23:48 |
The Outcome of the NexGen CR-Flex Mobile Bearing Knee Prosthesis:A multi centre non comparative prospective study
NexGen CR-Flex Mobile Clinical Study
The Outcome of the NexGen CR-Flex Mobile Bearing Knee Prosthesis:A multi centre non comparative prospective study
NexGen CR-Flex Mobile Clinical Study
Japan | Europe |
Severe knee pain and disability
Orthopedics |
Others
NO
To evaluate the clinical (functional and patient assessed) and radiographic outcome of the NexGen CR-Flex Mobile Bearing Knee.
Safety,Efficacy
Confirmatory
Not applicable
Clinical outcomes evaluated by the Knee Society assessment scoring system
-The functional outcome evaluated by the Knee Society functional scoring system
-Radiographic outcome evaluated by anterial -posterial and medial-lateral radiographs
-Patient's general health status assessment using the Euro-Qol-5D scoring system (EQ-5D)
-The survivorship meaning that the prosthesis has not been explanted, nor is a revision planned or pending
Observational
20 | years-old | <= |
80 | years-old | >= |
Male and Female
-Patients which are indicated for total knee replacement surgery suffering from severe knee pain and disability due to degenerative joint disease including the following: osteoarthritis (OA), primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle or pseudo gout, posttraumatic arthritis and varus, valgus, or flexion deformities.
-Patient is in stable health and able to undergo surgery and participate in a follow-up program based upon physical examination and medical history.
-Patient is willing and able to cooperate in follow-up program.
-Patient or patient's legal representative has signed a Patient Informed Consent Form.
-Patient is skeletally immature.
-Patient known to be pregnant.
-Varus/valgus deformity with mechanical axis >20 degrees.
-Fixed flexion deformity >15 degrees.
-Patients with grossly insufficient femoral or tibial bone stock, e.g., due to osteoporosis, metabolic bone disease, congenital anomaly, or previous surgery to the index joint that could affect outcome.
-Patients with previously failed knee endoprosthesis of any kind.
-Patients with a previous history of infection in the affected joint.
-Patient is unwilling or unable to cooperate in a follow-up program.
200
1st name | |
Middle name | |
Last name | Ryuichi Gejo |
University of Toyama
Department of Orthopaedic Surgery, Faculty of Medicine
2630 Sugitani Toyama-City Toyama, Japan
076-434-7353
rgejo@med.u-toyama.ac.jp
1st name | |
Middle name | |
Last name | Akira Kashima |
Zimmer K.K.
Clinical Affairs
7F, Kamiyacho Prime Place, 1-17, Toranomon 4-chome, Minato-ku, Tokyo, Japan
03-6402-6610
akira.kashima@zimmer.com
Zimmer K.K.
Zimmer K.K.
Profit organization
Japan
NO
富山大学附属病院(富山県)、社会医療法人愛仁会 高槻病院(大阪府)、カッセル整形外科クリニック(ドイツ)、コヴェントリー・ウォリックシャ-病院 NHSトラスト(イギリス)、ナンシー中央病院(フランス)
2011 | Year | 03 | Month | 28 | Day |
Unpublished
Completed
2009 | Year | 11 | Month | 02 | Day |
2011 | Year | 01 | Month | 31 | Day |
2011 | Year | 04 | Month | 01 | Day |
2023 | Year | 06 | Month | 30 | Day |
Multi-center, Prospective, Uncontrolled Clinical Study
2011 | Year | 03 | Month | 28 | Day |
2023 | Year | 10 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006340
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