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

Description

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

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Adult Spinal Deformity
Intervention / Treatment

-

Contacts and Locations

Phoenix

Barrow Neurological Institute, Phoenix, Arizona, United States, 85013

La Jolla

Shiley Center for Orthopaedic Research and Education at Scripps Clinic, La Jolla, California, United States, 92037

San Francisco

University of California - San Francisco, San Francisco, California, United States, 94143

Denver

Presbyterian/St. Luke's Medical Center, Denver, Colorado, United States, 80218

Shreveport

Louisiana Spine Institute, Shreveport, Louisiana, United States, 71101

Buffalo

University at Buffalo, Department of Neurosurgery, Buffalo, New York, United States, 14260-1660

New York

New York University, Department of Orthopedic Surgery, New York, New York, United States, 10003

Durham

Duke University Health System, Durham, North Carolina, United States, 27710

Charlottesville

University of Virginia, Charlottesville, Virginia, United States, 22908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

International Spine Study Group Foundation,

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

Study Record Dates

2034-12-31