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
Launched by INTERNATIONAL SPINE STUDY GROUP FOUNDATION · May 11, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new system called the VersaTie Posterior Fixation System, which aims to help prevent a problem called proximal junctional failure in patients undergoing surgery for certain spinal conditions, such as scoliosis or kyphosis. Proximal junctional failure can occur after spinal fusion surgery, leading to complications, so this trial hopes to see if the VersaTie system can improve outcomes for patients who are getting a long spinal fusion.
To be eligible for this study, participants need to be adults over 18 years old who are scheduled for surgery in the next six months. They should have a specific type of spinal fusion that involves at least five levels of the spine and will have the VersaTie system used in their surgery. Patients with active spine tumors, infections, or certain other conditions will not be able to participate. Those who join the trial can expect to undergo their usual surgical procedures and will be asked to complete some questionnaires to help researchers gather information about their recovery. This study is currently recruiting participants, and it is open to individuals of any gender.
Gender
ALL
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
About International Spine Study Group Foundation
The International Spine Study Group Foundation (ISSGF) is a leading organization dedicated to advancing research and clinical practices in spine surgery and care. Comprising a network of experts in the field, the foundation focuses on facilitating high-quality, multi-center clinical trials aimed at improving patient outcomes and enhancing the understanding of spinal disorders. Through collaboration with healthcare professionals, academic institutions, and industry partners, the ISSGF promotes evidence-based approaches to spine treatment, aiming to establish best practices and develop innovative solutions for complex spinal conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Charlottesville, Virginia, United States
Phoenix, Arizona, United States
Durham, North Carolina, United States
San Francisco, California, United States
Charlottesville, Virginia, United States
Denver, Colorado, United States
La Jolla, California, United States
New York, New York, United States
New York, New York, United States
Shreveport, Louisiana, United States
Buffalo, New York, United States
Charlottesville, Virginia, United States
Patients applied
Trial Officials
Shay Bess, MD
Principal Investigator
Presbyterian/St Luke's Medical Center
Jeffrey Mullin, MD
Principal Investigator
University at Buffalo, Department of Neurosurgery
Christopher Shaffrey, MD
Principal Investigator
Duke University Medical Center, Section of Spine Surgery
Justin Smith, MD
Principal Investigator
University of Virginia Medical Center, Department of Neurosurgery
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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