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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

ScoliosisAdult Spinal DeformityKyphosis

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.

Locations(9)

Barrow Neurological Institute

Phoenix, Arizona, United States

Shiley Center for Orthopaedic Research and Education at Scripps Clinic

La Jolla, California, United States

University of California - San Francisco

San Francisco, California, United States

Presbyterian/St. Luke's Medical Center

Denver, Colorado, United States

Louisiana Spine Institute

Shreveport, Louisiana, United States

University at Buffalo, Department of Neurosurgery

Buffalo, New York, United States

New York University, Department of Orthopedic Surgery

New York, New York, United States

Duke University Health System

Durham, North Carolina, United States

University of Virginia

Charlottesville, Virginia, United States

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NCT04888104

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