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
International Spine Study Group Foundation
Summary
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
Description
Specific Aims: * Evaluate the safety and performance of posterior spinal fusion constructs supplemented with posterior spinolaminar fixation using the VersaTie System compared to posterior fixation constructs without VersaTie System supplementation in adult patients undergoing long posterior spinal fusion by evaluating intraoperative and postoperative complications, clinical and radiographic outcomes, patient-reported outcomes (PROs) and need for revision surgery. * Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients, in…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Not specified
Inclusion Criteria: 1. \>18 years of age at the time of treatment 2. EOS full body or standing 36" AP \& Lateral images of entire spine 3. Posterior spine fusion with pedicle screw fixation construct of 5 or more levels 4. Pedicle screw fixation to be supplemented proximally with NuVasive VersaTie system 5. Upper instrumented vertebra (UIV) terminating at a newly instrumented level 6. Lowest instrumented vertebra (LIV) sacrum/pelvis 7. Surgery scheduled to take place in the next 6 months Exclusion Criteria: 1. Active spine tumor or infection 2. Deformity due to acute trauma 3. Prisoners 4.…
Interventions
- ProcedureIndex or revision spine surgery for complex adult spinal deformity
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.
Locations (9)
- Barrow Neurological InstitutePhoenix, Arizona
- Shiley Center for Orthopaedic Research and Education at Scripps ClinicLa Jolla, California
- University of California - San FranciscoSan Francisco, California
- Presbyterian/St. Luke's Medical CenterDenver, Colorado
- Louisiana Spine InstituteShreveport, Louisiana
- University at Buffalo, Department of NeurosurgeryBuffalo, New York