Recruiting

VersaTie

Sponsor:

International Spine Study Group Foundation

Code:

NCT04888104

Conditions

Adult Spinal Deformity

Scoliosis

Kyphosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Index or revision spine surgery for complex adult spinal deformity

Study Details

Brief 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

Study ID

NCT04888104

Start date

Jul 9, 2021

Status verified date

Feb, 2026

Completion date

Dec 31, 2034

Anticipated

Primary completion date

Dec 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

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

Study Design

Enrollment

225 participants

Anticipated

Interventions and Outcome Measures

Arms

VersaTie

Interventions

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.

Primary outcome measure

  • Scoliosis Research Society (SRS) 22r [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
  • Oswestry [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
  • Veterans RAND 12 Item Health Survey (VR-12) [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
  • Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
  • Patient-Reported Outcome Measurement Information System (PROMIS) - Depression [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
  • Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
  • Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
  • Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
  • Patient-Reported Outcome Measurement Information System (PROMIS) - Social Role [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
  • Visual Analog Scale - Back Pain [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]
  • Visual Analog Scale - Leg Pain [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]

Central Contacts and Locations

Central contacts

Christine Baldus, MH

6184444130baldusc@wustl.edu

Ray Pinteric

ray.pinteric@outlook.com

Locations

Barrow Neurological Institute

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Caleb Fisher

caleb.fisher900@commonspirit.org

Principal Investigator:

Jay Turner, MD

Shiley Center for Orthopaedic Research and Education at Scripps Clinic

Recruiting

La Jolla, California, United States, 92037

Contacts

Paulina de la Garza

858-554-7124delaGarza.Paulina@scrippshealth.org

Principal Investigator:

Gregory Mundis, MD

Presbyterian/St. Luke's Medical Center

Recruiting

Denver, Colorado, United States, 80218

Contacts

Bret Line

breton.line@gmail.com

Principal Investigator:

Shay Bess

Louisiana Spine Institute

Recruiting

Shreveport, Louisiana, United States, 71101

Contacts

Cody McConnell

CMcConnell@louisianaspine.org

Principal Investigator:

Pierce Nunley, MD

University at Buffalo, Department of Neurosurgery

Recruiting

Buffalo, New York, United States, 14260-1660

Contacts

Nicole Armstrong

narmstrong@ubns.com

Principal Investigator:

Jeffrey Mullin, MD

New York University, Department of Orthopedic Surgery

Recruiting

New York, New York, United States, 10003

Contacts

Connie Maglaras

constance.maglaras@nyulangone.org

Principal Investigator:

Themistocles Protopsaltis, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Lorrie Sipe

434-924-8875lag3k@virginia.edu

Principal Investigator:

Justin Smith, MD

More Information

Sponsor

International Spine Study Group Foundation

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • Scoliosis
  • Kyphosis
  • Sagittal Imbalance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by International Spine Study Group Foundation on 2026-02-17.