VersaTie Posterior Fixation for Adult Spinal Deformity

Recruiting at 8 trial locations

Overseen By Ray Pinteric

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: International Spine Study Group Foundation

Disqualifiers: Spine tumor, Infection, Trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Surgical procedure

225 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new system called the VersaTie Posterior Fixation System to determine its effectiveness in preventing proximal junctional failure, a type of spine issue, in individuals who have undergone long spinal fusion surgeries. The trial seeks to prevent post-surgery complications by providing extra support to the spine. Suitable candidates for this trial have a planned spinal fusion surgery involving at least five levels of the spine and will receive additional support with the VersaTie system. As a Phase 2 trial, this research measures the effectiveness of the VersaTie system in an initial, smaller group, offering participants the opportunity to contribute to significant advancements in spinal surgery care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the VersaTie Posterior Fixation System is safe for preventing proximal junctional failure?

Research shows that the VersaTie Posterior Fixation System supports the spine during surgery. This system is available on the market for spinal support, providing temporary stability until the spine heals and new bone forms.

The FDA has approved the system, indicating it meets specific safety standards. It holds the spine in place during surgery and attaches to parts of the backbone. FDA approval confirms its general safety, with most patients experiencing no serious side effects. Although no treatment is entirely risk-free, the approval process ensures thorough safety testing.

For those considering a trial with this system, existing research suggests it has been used safely before. However, discussing any concerns with a doctor is essential. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for preventing proximal junctional failure after spinal fusion rely on standard fixation techniques that can sometimes fall short over time. The VersaTie Posterior Fixation System stands out because it offers a novel approach to stabilization, potentially providing better long-term support and reducing stress on adjacent spinal segments. Researchers are excited about this system because it could significantly lower the risk of complications after surgery, improving patient outcomes and quality of life.

What evidence suggests that the VersaTie Posterior Fixation System is effective for preventing proximal junctional failure?

Research has shown that the VersaTie Posterior Fixation System effectively supports spinal fusion surgeries. One study found that 88% of treated areas successfully fused when using this system with other surgical techniques. Another report highlights that minimally invasive procedures, which can include the VersaTie System, are both possible and effective for treating spinal issues in adults. Additionally, a review of 71 patients showed positive results with long-segment spinal support using the VersaTie. Overall, these findings suggest that the VersaTie System could help prevent complications, such as issues with the spine above the treated area, in spinal surgeries. ^{3 6 7 8 9}

Who Is on the Research Team?

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

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

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

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04888104

Study Details | NCT04888104 | Prospective, Multicenter, ... Evaluate the safety and performance of posterior spinal fusion constructs supplemented with posterior spinolaminar fixation using the VersaTie System compared ...

2. spinalsurgerynews.com spinalsurgerynews.com/2021/04/nuvasive-and-the-international-spine-study-group-foundation-announce-expanded-long-term-partnership-with-initiation-of-additional-clinical-studies/71321

NuVasive and the International Spine Study Group ... Initial reports from the ongoing study show that minimally invasive surgery (MIS) is a feasible and effective approach for treating adult spinal ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5685966/

Lateral Lumbar Interbody Fusion—Outcomes and Complications In 88% of the treated levels, a successful fusion was achieved [36]. Strom et al. evaluated the combination of LLIF and open posterior surgery ...

4. ijssurgery.com ijssurgery.com/custom-print/50668

Use of Tethers for Proximal Junctional Kyphosis ... The fourth study34 reported a retrospective case series of 71 ASD patients treated with long-segment posterior instrumentation and tethering using the VersaTie ...

5. youtube.com youtube.com/watch?v=2o2wsEQUuyM

Pediatric and Adult Applications of Posterior Bands In this episode, Dr. Patrick Sugrue and Dr. Yashar Javidan discuss the use of VersaTie for supplemental fixation, translation in complex ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/K190418.pdf

Special 510(k) Premarket Notification - accessdata.fda.gov The VersaTie System is part of a spinal posterior fixation system designed to provide an interface between spinal anatomy and a rod used in spinal surgery ...

7. nuvasive.com nuvasive.com/wp-content/uploads/2021/11/VersaTie-System-Patient-Information-Leaflet_Final.pdf

VersaTie System Patient Information Leaflet The purpose of spinal fusion implants is to provide short-term stability until new bone growth takes place. Spinal fusion typically occurs within. 12 months of ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf16/K161265.pdf

NuVasive, Incorporated Ms. Cynthia Adams Regulatory Affairs ... The device is secured around posterior vertebral structures such as the lamina, facet, and transverse processes from T1-L5. The system is ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/10422216/

The Olerud Cervical Fixation System; a study of safety and ... The Olerud Cervical Spine Fixation System is versatile in posterior fixation of the cervical spine and has proven to be both safe and efficient. MeSH terms.