two consecutive levels radiculopathy or myelopathy involving herniated disc or osteophyte formation
Conditions
Interventions
None listed
Sponsors
Medtronic Sofamor Danek, Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactShigeaki Sakurai
Medtronic Japan Co., Ltd. Japan Clinical and Medical Affairs
Outcome results
None listed