This is a prospective, multi-center, non-randomized post-market evaluation designed to collect and evaluate data on the safety and performance of the Fortilink IBF System with TETRAfuse 3D Technology.
This is a prospective, multi-center, non-randomized post-market evaluation designed to collect and evaluate data on the safety and performance of the Fortilink IBF System with TETRAfuse 3D Technology. There will be 3 arms in the study, one for each configuration of the Fortilink IBF system (Fortilink-C, Fortilink-TS and Fortilink-L). Up to 50 subjects will be enrolled in each study arm for a total of up to 150 subjects at up to 20 sites in the United States (US) and European Union (EU).
Study Type
OBSERVATIONAL
Enrollment
15
Cervical and lumbar fusion
Los Angeles Orthopedic Institute
Sherman Oaks, California, United States
Rocky Mountain Spine Clinic
Lone Tree, Colorado, United States
Florida Back Institute
Rate of cervical fusion evaluated by radiographic evidence
Time frame: 12 months
Rate of lumbar fusion evaluated by radiographic evidence
Time frame: 24 months
Change in pain from baseline evaluated by use of subject-reported 100mm Visual Analogue Scale (VAS)
The VAS pain scale ranges from 0 to 100 where 0 represents No Pain and 100 represents Unbearable Pain.
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Radiographic findings by CT evaluation
Time frame: 12 months and 24 months
Time to return to work
Time frame: up to 24 months
Incidence of serious device related adverse events
Time frame: up to 24 months
Incidence of serious procedure related adverse events
Time frame: up to 24 months
Change in functional ability determined by Neck Disability Index (NDI) or Oswestry Disability Index (ODI)
The NDI is a subject questionnaire designed to assess neck pain and will only be completed by subjects who undergo cervical implants. The ODI is a subject questionnaire designed to assess back pain and will only be completed by subjects who undergo lumbar implants. Each questionnaire consists of a total score ranging from 0 to 100 where a lower score represents a better outcome and a higher score represents a worse outcome.
Time frame: 3 months, 6 months, 12 months, and 24 months
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Boca Raton, Florida, United States
South Florida Spine & Orthopaedics
Coconut Creek, Florida, United States
Spine Institute of South Florida
Delray Beach, Florida, United States
Indiana Spine Center
Indianapolis, Indiana, United States
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, United States
OrthoBethesda
Bethesda, Maryland, United States
ReVive Spine Center
Niagara Falls, New York, United States
The Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, United States
...and 4 more locations
Change in quality of life determined by SF-12 questionnaire
SF-12 questionnaires scores are computed and range from 0 to 100 where a 0 score indicates the lowest level of health and 100 indicates the highest level of health.
Time frame: 3 months, 6 months, 12 months, and 24 months
Change in pain medication usage from baseline
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months