NuVasive
The objective of this study is to evaluate the safety and performance of occipito-cervico-thoracic spine surgery using posterior fixation as measured by reported complications, radiographic outcomes, and patients reported outcomes (PROs).This study is being undertaken to identify possible residual risks and to clarify mid-to long-term clinical performance that may affect the benefit/risk ratio of posterior fixation systems.
This study is a prospective, uncontrolled, multicenter study to evaluate the safety and performance of select occipito-cervico-thoracic posterior fixation systems in patients who undergo posterior fixation fusion surgery. Consecutive patients at a given site who meet eligibility requirements will be asked to consent to participate in the study. These patients will present with traumatic, reconstructive, and/or tumor conditions in the craniocervical, cervical, and/or upper thoracic spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled in the…
Inclusion Criteria: 1. Patients who are ≥18 years of age at the time of consent 2. Have planned craniocervical, cervical (C1 to C7), and/or upper thoracic (T1-T3) spine surgery using posterior fixation planned for treatment of any of the following conditions: 1. traumatic spinal fractures and/or traumatic dislocations 2. instability or deformity 3. failed previous fusions (e.g., pseudoarthrosis) 4. tumors involving the cervical spine 5. degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiogr…
observational