225 Participants Needed

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 at 8 trial locations
CB
RP
Overseen ByRay Pinteric
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: International Spine Study Group Foundation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

JM

Jeffrey Mullin, MD

Principal Investigator

University at Buffalo, Department of Neurosurgery

CS

Christopher Shaffrey, MD

Principal Investigator

Duke University Medical Center, Section of Spine Surgery

JS

Justin Smith, MD

Principal Investigator

University of Virginia Medical Center, Department of Neurosurgery

SB

Shay Bess, MD

Principal Investigator

Presbyterian/St Luke's Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

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
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo long posterior spinal fusion surgery with or without the VersaTie System

Surgical procedure

Postoperative Monitoring

Participants are monitored for intraoperative and postoperative complications, clinical and radiographic outcomes, and patient-reported outcomes

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years
Follow-up visits at 3 months, 1, 2, 5, and 10 years

What Are the Treatments Tested in This Trial?

Interventions

  • VersaTie Posterior Fixation System

Find a Clinic Near You

Who Is Running the Clinical Trial?

International Spine Study Group Foundation

Lead Sponsor

Trials
6
Recruited
1,600+

NuVasive

Industry Sponsor

Trials
46
Recruited
28,000+
Unbiased ResultsWe believe in providing patients with all the options.
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