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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Barrow Neurological Institute
  Phoenix, Arizona, United States Recruiting
• Shiley Center for Orthopaedic Research and Education at Scripps Clinic
  La Jolla, California, United States Recruiting
• 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

Study contacts

• Principal investigator: Shay Bess, MD — Presbyterian/St Luke's Medical Center
• Study coordinator: Christine Baldus, MH
• Email: baldusc@wustl.edu
• Phone: 6184444130

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.