Status:
RECRUITING
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
Lead Sponsor:
International Spine Study Group Foundation
Collaborating Sponsors:
NuVasive
Conditions:
Adult Spinal Deformity
Scoliosis
Eligibility:
All Genders
18+ years
Brief 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
Detailed 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 c...
Eligibility Criteria
Inclusion
- \>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
- Upper instrumented vertebra (UIV) terminating at a newly instrumented level
- Lowest instrumented vertebra (LIV) sacrum/pelvis
- Surgery scheduled to take place in the next 6 months
Exclusion
- Active spine tumor or infection
- Deformity due to acute trauma
- Prisoners
- Women who are pregnant
- Patient is unwilling or unable to complete questionnaires
Key Trial Info
Start Date :
July 9 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2034
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT04888104
Start Date
July 9 2021
End Date
December 31 2034
Last Update
April 30 2025
Active Locations (9)
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1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
2
Shiley Center for Orthopaedic Research and Education at Scripps Clinic
La Jolla, California, United States, 92037
3
University of California - San Francisco
San Francisco, California, United States, 94143
4
Presbyterian/St. Luke's Medical Center
Denver, Colorado, United States, 80218