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Observational Study of VersaTie System for Spinal Fusion

This observational study is looking at how well the VersaTie Posterior Fixation System works to prevent problems after long spinal fusion surgeries in adults. Researchers will compare patients who receive the VersaTie System with those who don't, to see if it reduces complications and improves patient well-being. You might be able to join if you are an adult (18 years or older) having a spinal fusion surgery of at least 5 levels, where the VersaTie system is used. Success will be measured by changes in your quality of life, pain, and disability scores (like the Scoliosis Research Society (SRS) 22r and Oswestry scores) over 10 years. The current status of this study is unclear, and it aims to enroll 225 participants.

Study design
This is an observational study, meaning researchers will watch and collect information from patients undergoing spinal fusion surgery. It is a case-control analysis, comparing patients who receive the VersaTie system to those who do not. The study plans to enroll 225 participants.
What's involved
You would have your spinal fusion surgery and then complete questionnaires at 3 months, 1, 2, 5, and 10 years after your surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 10 years after their surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04888104

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

Recruiting
Not specifiedAges 18+Observational
International Spine Study Group Foundation
~225 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:Index or revision spine surgery for complex adult spinal deformity

At a glance

Recruiting sites
7 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Scoliosis Research Society (SRS) 22r
Measured over Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
+10 more outcomes measured

Conditions

Adult Spinal Deformity
Scoliosis
Kyphosis

Explore related trials

Adult Spinal DeformityKyphosisSagittal imbalanceScoliosis

NCT04888104

Where you'd take part

This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Barrow Neurological Institute

    Phoenix, Arizonastudy coordinator listed

    Recruiting

  • Duke University Health System

    Durham, North Carolinastudy coordinator listed

    Not yet recruiting

  • Louisiana Spine Institute

    Shreveport, Louisianastudy coordinator listed

    Recruiting

  • New York University, Department of Orthopedic Surgery

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Presbyterian/St. Luke's Medical Center

    Denver, Coloradostudy coordinator listed

    Recruiting

  • Shiley Center for Orthopaedic Research and Education at Scripps Clinic

    La Jolla, Californiastudy coordinator listed

    Recruiting

  • University at Buffalo, Department of Neurosurgery

    Buffalo, New Yorkstudy coordinator listed

    Recruiting

  • University of Virginia

    Charlottesville, Virginiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • 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

Who to contact

Christine Baldus, MH
[email protected]
6184444130
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • Scoliosis Research Society (SRS) 22rChange from Preop to 3 months and 1, 2, 5 & 10 year follow-up

    Scoliosis specific patient reported outcome

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

    Spine specific patient reported outcome

  • Veterans RAND 12 Item Health Survey (VR-12)Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up

    Patient reported outcome

  • Patient-Reported Outcome Measurement Information System (PROMIS) - AnxietyChange from Preop to 3 months and 1, 2, 5 & 10 year follow-up

    Patient reported outcome

  • Patient-Reported Outcome Measurement Information System (PROMIS) - DepressionChange from Preop to 3 months and 1, 2, 5 & 10 year follow-up

    Patient reported outcome

  • Patient-Reported Outcome Measurement Information System (PROMIS) - Pain InterferenceChange from Preop to 3 months and 1, 2, 5 & 10 year follow-up

    Patient reported outcome

  • Patient-Reported Outcome Measurement Information System (PROMIS) - Physical FunctionChange from Preop to 3 months and 1, 2, 5 & 10 year follow-up

    Patient reported outcome

  • Patient-Reported Outcome Measurement Information System (PROMIS) - Social SatisfactionChange from Preop to 3 months and 1, 2, 5 & 10 year follow-up

    Patient reported outcome

  • Patient-Reported Outcome Measurement Information System (PROMIS) - Social RoleChange from Preop to 3 months and 1, 2, 5 & 10 year follow-up

    Patient reported outcome

  • Visual Analog Scale - Back PainChange from Preop to 3 months and 1, 2, 5 & 10 year follow-up

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

  • Visual Analog Scale - Leg PainChange from Preop to 3 months and 1, 2, 5 & 10 year follow-up

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