Evaluation of the Fortilink IBF System With TETRAfuse Technology
ENTRUST
1 other identifier
observational
119
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2018
Shorter than P25 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedStudy Start
First participant enrolled
November 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2019
CompletedOctober 2, 2019
September 1, 2019
2 months
October 5, 2018
September 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Safety outcomes associated with use of the Fortlink System
Safety assessment includes evaluation of all adverse events or complications related to the procedure and post-operative adverse events.
Up to 1 year
Interventions
Cervical and lumbar fusion
Eligibility Criteria
Patient must have had an attempted implant of the Fortilink IBF System
You may qualify if:
- Patient must have had an attempted implant of the Fortilink IBF System
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RTI Surgicallead
Study Sites (5)
Los Angeles Orthopedic Institute
Sherman Oaks, California, 91403, United States
Rocky Mountain Spine
Lone Tree, Colorado, 80124, United States
Florida Back Institute
Boca Raton, Florida, 33496, United States
Spine Institute of South Florida
Delray Beach, Florida, 33484, United States
OrthoBethesda
Bethesda, Maryland, 20817, United States
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2018
First Posted
October 9, 2018
Study Start
November 6, 2018
Primary Completion
January 15, 2019
Study Completion
January 15, 2019
Last Updated
October 2, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share