NCT04888104

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
105mo left

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Jul 2021Dec 2034

First Submitted

Initial submission to the registry

May 11, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 9, 2021

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2031

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2034

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

10.5 years

First QC Date

May 11, 2021

Last Update Submit

February 12, 2026

Conditions

Adult Spinal DeformityScoliosisKyphosis

Keywords

ScoliosisKyphosisSagittal Imbalance

Outcome Measures

Primary Outcomes (11)

  • Scoliosis Research Society (SRS) 22r

    Scoliosis specific patient reported outcome

    Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

  • Oswestry

    Spine specific patient reported outcome

    Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

  • Veterans RAND 12 Item Health Survey (VR-12)

    Patient reported outcome

    Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

  • Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety

    Patient reported outcome

    Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

  • Patient-Reported Outcome Measurement Information System (PROMIS) - Depression

    Patient reported outcome

    Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

  • Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference

    Patient reported outcome

    Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

  • Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function

    Patient reported outcome

    Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

  • Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction

    Patient reported outcome

    Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

  • Patient-Reported Outcome Measurement Information System (PROMIS) - Social Role

    Patient reported outcome

    Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

  • Visual Analog Scale - Back Pain

    Self-reported back pain on scale of 0 (No pain) to 10 (severe pain)

    Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

  • Visual Analog Scale - Leg Pain

    Self-reported leg pain on scale of 0 (No pain) to 10 (severe pain)

    Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

Secondary Outcomes (3)

  • Edmonton Frail Scale

    Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

  • Canadian Study of Health and Aging (CSHA)

    Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

  • Adverse Events

    3 months and 1, 2, 5 & 10 year post treatment

Study Arms (1)

VersaTie

Procedure: Index or revision spine surgery for complex adult spinal deformity

Interventions

Index or revision spine surgery for complex adult spinal deformityPROCEDURE

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.

Also known as: VersaTie System
VersaTie

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Multicenter, prospective, observational, study evaluating the safety and performance of the VersaTie System by comparing 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

You may qualify if:

  • \>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

You may not qualify if:

  • Active spine tumor or infection
  • Deformity due to acute trauma
  • Prisoners
  • Women who are pregnant
  • Patient is unwilling or unable to complete questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

RECRUITING

Shiley Center for Orthopaedic Research and Education at Scripps Clinic

La Jolla, California, 92037, United States

RECRUITING

University of California - San Francisco

San Francisco, California, 94143, United States

WITHDRAWN

Presbyterian/St. Luke's Medical Center

Denver, Colorado, 80218, United States

RECRUITING

Louisiana Spine Institute

Shreveport, Louisiana, 71101, United States

RECRUITING

University at Buffalo, Department of Neurosurgery

Buffalo, New York, 14260-1660, United States

RECRUITING

New York University, Department of Orthopedic Surgery

New York, New York, 10003, United States

RECRUITING

Duke University Health System

Durham, North Carolina, 27708, United States

NOT YET RECRUITING

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

ScoliosisKyphosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Shay Bess, MD

    Presbyterian/St Luke's Medical Center

    PRINCIPAL INVESTIGATOR

  • Jeffrey Mullin, MD

    University at Buffalo, Department of Neurosurgery

    PRINCIPAL INVESTIGATOR

  • Christopher Shaffrey, MD

    Duke University Medical Center, Section of Spine Surgery

    PRINCIPAL INVESTIGATOR

  • Justin Smith, MD

    University of Virginia Medical Center, Department of Neurosurgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Baldus, MH

CONTACT

6184444130baldusc@wustl.edu

Ray Pinteric

CONTACT

ray.pinteric@outlook.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2021

First Posted

May 17, 2021

Study Start

July 9, 2021

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2034

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(9)