Unique ID issued by UMIN | UMIN000038925 |
---|---|
Receipt number | R000044388 |
Scientific Title | PRESTIGE LP Cervical Disc System (2 levels) Regulated PMS |
Date of disclosure of the study information | 2020/01/20 |
Last modified on | 2022/06/23 13:41:09 |
PRESTIGE LP Cervical Disc System (2 levels) Regulated PMS
PRESTIGE LP Cervical Disc System (2 levels) Regulated PMS
PRESTIGE LP Cervical Disc System (2 levels) Regulated PMS
PRESTIGE LP Cervical Disc System (2 levels) Regulated PMS
Japan |
two consecutive levels radiculopathy or myelopathy involving herniated disc or osteophyte formation
Orthopedics | Neurosurgery |
Others
NO
The purpose of this use results survey is to assess safety and effectiveness of PRESTIGE LP Cervical Disc System(hereafter referred to the product) that is applied to the patients unresponsive to at least three months of non-operative therapy with radiculopathy or myelopathy at two consecutive levels involving herniated disc or osteophyte formation observed under imaging tests.
Safety,Efficacy
Confirmatory
Pragmatic
Among adverse events/deficiencies, secondary surgeries and implant-related events (subsidence, migration, etc.)
(1) Secondary surgery
Surgical procedures at the treated level, including revision, removal, supplemental fixation and reoperation
(2) Implant-related event
Subsidence of implant, fall of implant, migration of implant, or other implant-related event
Observational
1 | Not applicable | <= |
100 | Not applicable | >= |
Male and Female
Patients unresponsive to at least three months of non-operative therapy with radiculopathy or myelopathy at two consecutive levels involving herniated disc or osteophyte formation observed under imaging tests.
1) Patients allergic to metals
2) Patients in the process of active infection, or with a serious risk of infection such as an immunodeficiency
3) Patients with a disease that involves severe bone fragility, (or with a cervical vertebra so fragile as to experience difficulty in receiving an implant due to diseases such as severe osteoporosis, osteomalacia, Paget's disease of bone, renal osteodystrophy, Ehlers-Danlos Syndrome, osteogenesis imperfecta, etc.)
4) Patients with notable cervical instability under the lateral images of ante-/retro-flexion
5) Patients with either of the following severe cervical diseases:
(1) Bridging osteophyte formation observed at the treated level without maintaining mobility
(2) Significantly-narrowing intervertebral height observed at the treated level
6) Patients with a severe facet joint arthrosis at the treated level
7) Patients with a significant lesion or deformity of vertebral body
8) Patients presenting obvious abnormality in cervical alignment (e.g. local kyphosis)
9) Patients presenting an obvious cervical spinal canal stenosis across multiple levels
10) Patients with a trauma involving cervical bone fracture, ligament injury, etc.
11) Patients presenting obvious involuntary movement at the head and neck area
42
1st name | Akira |
Middle name | |
Last name | Kikuchi |
Medtronic Sofamor Danek, Co., Ltd.
Clinical
108-0075
Shinagawa Season Terrace 1-2-70 Konan, Minato-ku, Tokyo 108-0075 Japan
03-6776-0007
akira.kikuchi@medtronic.com
1st name | Shigeaki |
Middle name | |
Last name | Sakurai |
Medtronic Japan Co., Ltd.
Japan Clinical and Medical Affairs
108-0075
Shinagawa Season Terrace 1-2-70 Konan, Minato-ku, Tokyo 108-0075 Japan
03-6776-1406
sakurs2@medtronic.com
Medtronic Sofamor Danek, Co., Ltd.
None
Profit organization
Tokyo Medical and Dental University Hospital
1-5-45 Yushima, Bunkyo-ku, Tokyo
03-5803-4575
mkan-rinsho.adm@tmd.ac.jp
NO
2020 | Year | 01 | Month | 20 | Day |
Unpublished
No longer recruiting
2019 | Year | 11 | Month | 10 | Day |
2020 | Year | 02 | Month | 25 | Day |
2020 | Year | 03 | Month | 13 | Day |
2024 | Year | 10 | Month | 31 | Day |
The purpose of this use results survey is to assess safety and effectiveness of PRESTIGE LP Cervical Disc System (hereafter referred to the product) that is applied to the patients unresponsive
to at least three months of non-operative therapy with radiculopathy or myelopathy at two consecutive levels involving herniated disc or osteophyte formation observed under imaging tests.
2019 | Year | 12 | Month | 18 | Day |
2022 | Year | 06 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044388
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |