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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
International Spine Study Group Foundation
Study ID
NCT04888104
Status
Recruiting
Apply to this trial

Conditions

  • Adult Spinal Deformity
  • Kyphosis
  • Scoliosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Index or revision spine surgery for complex adult spinal deformity — PROCEDURE
    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.

Study Details

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

Key Dates

Start date
Jul 9, 2021
Status verified
Feb 2026
Primary completion
Dec 31, 2031
Completion
Dec 31, 2034

Study Design

Enrollment
225 participants (estimated)

Arms

  • Arm: VersaTie

Primary Outcome Measure

Scoliosis Research Society (SRS) 22r [ Time Frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Barrow Neurological InstitutePhoenixArizona85013
Caleb Fisher
[email protected]
Jay Turner, MD (PRINCIPAL_INVESTIGATOR)
Shiley Center for Orthopaedic Research and Education at Scripps ClinicLa JollaCalifornia92037
Paulina de la Garza
[email protected]
858-554-7124
Gregory Mundis, MD (PRINCIPAL_INVESTIGATOR)
Robert Eastlack, MD (SUB_INVESTIGATOR)
University of California - San FranciscoSan FranciscoCalifornia94143-
Presbyterian/St. Luke's Medical CenterDenverColorado80218
Shay Bess (PRINCIPAL_INVESTIGATOR)
Louisiana Spine InstituteShreveportLouisiana71101
Cody McConnell
[email protected]
Pierce Nunley, MD (PRINCIPAL_INVESTIGATOR)
University at Buffalo, Department of NeurosurgeryBuffaloNew York14260-1660
Nicole Armstrong
[email protected]
Jeffrey Mullin, MD (PRINCIPAL_INVESTIGATOR)
New York University, Department of Orthopedic SurgeryNew YorkNew York10003
Connie Maglaras
[email protected]
Themistocles Protopsaltis, MD (PRINCIPAL_INVESTIGATOR)
Duke University Health SystemDurhamNorth Carolina27708
Ronald Pegues
[email protected]
Christopher I Shaffrey, MD (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22908
Lorrie Sipe
[email protected]
434-924-8875
Justin Smith, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By research site
Barrow Neurological Institute· Phoenix, AZShiley Center for Orthopaedic Research and Education at Scripps Clinic· La Jolla, CAUniversity of California - San Francisco· San Francisco, CAPresbyterian/St. Luke's Medical Center· Denver, COLouisiana Spine Institute· Shreveport, LAUniversity at Buffalo, Department of Neurosurgery· Buffalo, NY

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