Analysis of a new spinal fixation system to prevent complications in adult spinal surgery

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

This study tests if a new spinal fixation system can help adults undergoing spinal surgery avoid complications and improve their recovery compared to traditional methods.

Quick facts

• Study type: Observational
• Enrollment: 225 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: International Spine Study Group Foundation (other)
• Locations: 9 sites (Phoenix, Arizona and 8 other locations)
• Trial ID: NCT04888104 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the VersaTie Posterior Fixation System in preventing proximal junctional failure in long posterior spinal fusion surgeries for adults. It compares outcomes between patients using the VersaTie system and those who do not, focusing on complications, clinical results, and patient-reported outcomes. The study also aims to establish best practices for treating complex adult spinal deformities and develop a standardized classification system for complications in spine surgery. Additionally, it assesses blood management strategies and opioid use in relation to patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old scheduled for long posterior spinal fusion surgery involving 5 or more levels of pedicle screw fixation.

Not a fit: Patients with active spine tumors, infections, or those who are pregnant will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing spinal fusion surgery.

How similar studies have performed: Other studies have shown promising results with similar fixation systems, indicating potential for success in this approach.

Eligibility criteria

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. Women who are pregnant
5. Patient is unwilling or unable to complete questionnaires

Where this trial is running

Phoenix, Arizona and 8 other locations

• Barrow Neurological Institute — Phoenix, Arizona, United States (RECRUITING)
• Shiley Center for Orthopaedic Research and Education at Scripps Clinic — La Jolla, California, United States (RECRUITING)
• University of California - San Francisco — San Francisco, California, United States (WITHDRAWN)
• Presbyterian/St. Luke's Medical Center — Denver, Colorado, United States (RECRUITING)
• Louisiana Spine Institute — Shreveport, Louisiana, United States (RECRUITING)
• University at Buffalo, Department of Neurosurgery — Buffalo, New York, United States (RECRUITING)
• New York University, Department of Orthopedic Surgery — New York, New York, United States (RECRUITING)
• Duke University Health System — Durham, North Carolina, United States (NOT_YET_RECRUITING)
• University of Virginia — Charlottesville, Virginia, United States (RECRUITING)

Study contacts

• Principal investigator: Shay Bess, MD — Presbyterian/St Luke's Medical Center
• Study coordinator: Christine Baldus, MH

Conditions: Adult Spinal Deformity, Scoliosis, Kyphosis, Sagittal Imbalance