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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

NCT04888104 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 225

Last updated 2026-02-17

No results posted yet for this study

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

Conditions

  • Adult Spinal Deformity
  • Scoliosis
  • Kyphosis

Interventions

PROCEDURE

Index 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.

Sponsors & Collaborators

  • NuVasive

    collaborator INDUSTRY

  • International Spine Study Group Foundation

    lead OTHER

Principal Investigators

  • Shay Bess, MD · Presbyterian/St Luke's Medical Center

  • Jeffrey Mullin, MD · University at Buffalo, Department of Neurosurgery

  • Christopher Shaffrey, MD · Duke University Medical Center, Section of Spine Surgery

  • Justin Smith, MD · University of Virginia Medical Center, Department of Neurosurgery

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-09
Primary Completion
2031-12-31
Completion
2034-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04888104 on ClinicalTrials.gov