Evaluation of the Fortilink IBF System With TETRAfuse Technology
- Conditions
- Cervical and Lumbar Fusion
- Registration Number
- NCT03699891
- Lead Sponsor
- RTI Surgical
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
- Patient must have had an attempted implant of the Fortilink IBF System
- There are no exclusion criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Spine Institute of South Florida
🇺🇸Delray Beach, Florida, United States
Rocky Mountain Spine
🇺🇸Lone Tree, Colorado, United States
Los Angeles Orthopedic Institute
🇺🇸Sherman Oaks, California, United States
Florida Back Institute
🇺🇸Boca Raton, Florida, United States
OrthoBethesda
🇺🇸Bethesda, Maryland, United States