Cervical and Lumbar Fusion
Conditions
Brief summary
This is a multi-center, post-market, retrospective study to collect safety and performance data for patients implanted with the Fortilink IBF System.
Detailed description
This is a multi-center, post-market, retrospective study to collect safety and performance data for patients implanted with the Fortilink IBF System. The study will include up to 110 patients at up to 8 US sites. All patients implanted with the Fortilink System at a site will be included in the data collection. The goal is to collect data for at least 100 subjects, but the sample size will be capped at 110 to ensure that all patients at a given site are included in the analysis.
Interventions
Cervical and lumbar fusion
Sponsors
RTI Surgical
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient must have had an attempted implant of the Fortilink IBF System
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety outcomes associated with use of the Fortlink System | Up to 1 year | Safety assessment includes evaluation of all adverse events or complications related to the procedure and post-operative adverse events. |
Countries
United States
Outcome results
None listed