Prospective, Multicenter, Case-Control Analysis of the VersaTie Posterior Fixation System to Prevent Proximal Junctional Failure in Long Posterior Spinal Fusion Constructs for Adult Patients
>18 years of age at the time of treatment
EOS full body or standing 36" AP & Lateral images of entire spine
Posterior spine fusion with pedicle screw fixation construct of 5 or more levels
Pedicle screw fixation to be supplemented proximally with NuVasive VersaTie system
Active spine tumor or infection
Deformity due to acute trauma
Prisoners
Women who are pregnant
Multicenter, prospective, observational, study evaluating the safety and performance of the VersaTie System by comparing adult patients receiving minimum 5 level posterior spinal fusion with pedicle screw fixation supplemented at the proximal aspect of the construct with the VersaTie System
Cohort
Prospective
Index or revision spine surgery for complex adult spinal deformity
Procedure/SurgeryAdult patients receiving minimum 5 level posterior spinal fusion with pedicle screw fixation supplemented at the proximal aspect of the construct with the VersaTie System.
Scoliosis Research Society (SRS) 22r
Scoliosis specific patient reported outcome
Oswestry
Spine specific patient reported outcome
Veterans RAND 12 Item Health Survey (VR-12)
Patient reported outcome
Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety
Patient reported outcome
Edmonton Frail Scale
Evaluate frailty on scale of 0 to 17 where higher scores mean more frail
Canadian Study of Health and Aging (CSHA)
Frailty scale of 1 to 9; higher scores mean more frail
Adverse Events
Occurrence of Adverse events meeting reporting criteria and their relationship to intervention throughout the study \[Time Frame: 3 months and 1, 2, 5 \& 10 year post treatment\]
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International Spine Study Group Foundation
Lead sponsor
NuVasive
Collaborator
