Spinal Disease, Spinal Instability, Spinal Stenosis Cervical, Spinal Stenosis Cervicothoracic Region, Spinal Stenosis Occipito-Atlanto-Axial
Conditions
Brief summary
This is a multi-center, post-market, retrospective study design to collect safety and performance data for patients implanted with the Streamline OCT System.
Detailed description
This is a multi-center, post-market, retrospective study design to collect safety and performance data for patients implanted with the Streamline OCT System. The study will include a minimum of 58 patients at a minimum of 3 sites in the United States. The study will enroll at a minimum of 5 subjects implanted with the occipital plate.
Interventions
DEVICEStreamline Occipito-Cervico-Thoracic Spinal Fixation System
Spinal Fixation
Sponsors
RTI Surgical
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Inclusion criteria
* Subject must have had an implant of the OCT System.
Exclusion criteria
* No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate time to demonstration of fusion. | 12 months | Evaluate time to demonstration of fusion. |
Countries
United States
Outcome results
None listed