RecruitingNCT04888104

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

Sponsor

International Spine Study Group Foundation

Enrollment

225 participants

Start Date

Jul 9, 2021

Study Type

OBSERVATIONAL

Conditions

Scoliosis Adult Spinal Deformity Kyphosis

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

Eligibility

Min Age: 18 Years

Inclusion Criteria7

>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 Criteria5

Active spine tumor or infection
Deformity due to acute trauma
Prisoners
Women who are pregnant
Patient is unwilling or unable to complete questionnaires

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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.