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

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Conditions

Adult Spinal DeformityScoliosisKyphosisSagittal Imbalance

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2021-07-09
Study Completion:2034-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04888104

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. \>18 years of age at the time of treatment
  2. 2. EOS full body or standing 36" AP \& Lateral images of entire spine
  3. 3. Posterior spine fusion with pedicle screw fixation construct of 5 or more levels
  4. 4. Pedicle screw fixation to be supplemented proximally with NuVasive VersaTie system
  5. 5. Upper instrumented vertebra (UIV) terminating at a newly instrumented level
  6. 6. Lowest instrumented vertebra (LIV) sacrum/pelvis
  7. 7. Surgery scheduled to take place in the next 6 months
  1. 1. Active spine tumor or infection
  2. 2. Deformity due to acute trauma
  3. 3. Prisoners
  4. 4. Women who are pregnant
  5. 5. Patient is unwilling or unable to complete questionnaires

Contacts and Locations

Study Contact

Christine Baldus, MH
CONTACT
6184444130
baldusc@wustl.edu
Ray Pinteric
CONTACT
ray.pinteric@outlook.com

Principal Investigator

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 Locations (Sites)

Barrow Neurological Institute
Phoenix, Arizona, 85013
United States
Shiley Center for Orthopaedic Research and Education at Scripps Clinic
La Jolla, California, 92037
United States
University of California - San Francisco
San Francisco, California, 94143
United States
Presbyterian/St. Luke's Medical Center
Denver, Colorado, 80218
United States
Louisiana Spine Institute
Shreveport, Louisiana, 71101
United States
University at Buffalo, Department of Neurosurgery
Buffalo, New York, 14260-1660
United States
New York University, Department of Orthopedic Surgery
New York, New York, 10003
United States
Duke University Health System
Durham, North Carolina, 27710
United States
University of Virginia
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-09
Study Completion Date2034-12-31

Study Record Updates

Study Start Date2021-07-09
Study Completion Date2034-12-31

Terms related to this study

Keywords Provided by Researchers

  • Scoliosis
  • Kyphosis
  • Sagittal Imbalance

Additional Relevant MeSH Terms

  • Adult Spinal Deformity
  • Scoliosis
  • Kyphosis