AVBT vs Spine Fusion for Scoliosis

Overseen By Orthopedic Study Office

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Congenital scoliosis, Neuromuscular disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Surgical procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for scoliosis, a condition where the spine curves sideways. Researchers aim to determine if Anterior Vertebral Body Tethering (AVBT), a surgical method using special components to straighten the spine, is safe in the short term for children and teens who have not yet finished growing. The trial will compare AVBT using Dynesys System Components to traditional spine fusion surgery to assess which is more effective. Children aged 10 to 16 with a moderate to severe scoliosis curve, who have at least a year of growth remaining, may be suitable candidates. As an unphased trial, this study provides a unique opportunity for participants to contribute to pioneering research that could enhance scoliosis treatment options for future patients.

Do I have to stop taking 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 AVBT using Dynesys System Components is safe for pediatric scoliosis patients?

Research has shown that Anterior Vertebral Body Tethering (AVBT) is a promising treatment for scoliosis in young patients. Studies have found that most patients tolerate AVBT well. Although some complications occur, they are usually less serious than those from traditional spine fusion surgeries.

The FDA has reviewed safety data for AVBT and supports its use. This data indicates that while some side effects have been reported, they are rare and generally manageable. AVBT is approved for use in certain cases, which adds confidence in its safety.

In summary, while all treatments carry risks, current studies and safety data suggest that AVBT is relatively safe for treating scoliosis in children, with side effects that are easier to manage compared to other surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about AVBT (Anterior Vertebral Body Tethering) for scoliosis because it offers a unique, less invasive alternative to traditional spine fusion surgery. Unlike fusion, which stabilizes the spine by fusing vertebrae together, AVBT uses the Dynesys System Components to provide flexibility by tethering the spine, allowing for continued growth and movement. This approach may reduce recovery time and preserve more natural spine function, which is particularly beneficial for pediatric patients whose spines are still developing.

What evidence suggests that this trial's treatments could be effective for scoliosis?

Research shows that Anterior Vertebral Body Tethering (AVBT), which participants in this trial may receive, is a promising treatment for scoliosis in children who are still growing. Studies indicate that AVBT can straighten the spine without fusing the bones. This method allows the spine to continue growing and remain flexible, a significant advantage for young patients. However, AVBT has moderate success rates and some surgical risks. Overall, AVBT offers a growth-friendly option for managing scoliosis in developing children. Meanwhile, another group in this trial will receive Spine Fusion as the control treatment. ^{1 2 5 6 7}

Who Is on the Research Team?

Noelle Larson, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for boys and girls aged 10-16 with moderate to severe scoliosis who still have at least a year of growth left. They must have specific types of scoliosis (Lenke 1, 2, 3C, or 5) with curves between 40-70 degrees. Participants need understanding parents who can consent and commit to follow-up visits. It's not for those pregnant, with certain allergies, substance abuse history, previous scoliosis surgery or other forms of scoliosis.

Inclusion Criteria

Parents must be able to understand the study and sign the consent document. Assent will be obtained and documented as age appropriate

Patients and parents must be able to comply with study procedures and visits, including 3-month, 1-year, and 2-year follow-up visits

Lenke 1, 2, 3C, 5 (thoracic, thoracolumbar, or thoracic and lumbar)

Exclusion Criteria

I have had surgery for scoliosis.

Known, reported allergies to titanium, PET, or PCU

I currently have an active infection in my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Anterior Vertebral Body Tethering (AVBT) or fusion surgery

Surgical procedure

Postoperative Monitoring

Participants are monitored for spinal disc health and curve flexibility using MRI and flexibility films

At least 1 year

Follow-up

Participants are monitored for major Cobb angle progression and revision surgery

2 years

What Are the Treatments Tested in This Trial?

Interventions

• AVBT using Dynesys System Components
• Spine Fusion

Trial Overview

The study is testing the safety of AVBT using Zimmer Biomet Tether System or Dynesys components in young patients with scoliosis against traditional spine fusion methods. Researchers will compare outcomes from both treatments over short-term follow-ups.

How Is the Trial Designed?

Group I: Pediatric Scoliosis Patients Experimental Treatment 1 Intervention

Tether group

Group II: Pediatric Scoliosis Control Patients Active Control 1 Intervention

Fusion (control) group

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03506334?cond=tethering%20scoliosis&viewType=Table&rank=4

Anterior Vertebral Body Tethering (AVBT) Using Zimmer ...

Zimmer Biomet Tether System and Dynesys System components are intended to treat scoliosis in skeletally immature children. Participant Group/Arm, Active ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9125003/

Anterior vertebral body tethering for idiopathic scoliosis in ...

AVBT is a promising growth-friendly technique for treatment of IS in growing patients. However, it has moderate success and perioperative complications.

3.

clinicaltrial.be

clinicaltrial.be/en/details/68809?only_active=0&only_eligible=0&only_recruiting=0&per_page=20

Anterior Vertebral Body Tethering (AVBT) Using Zimmer Bio...

Zimmer Biomet Tether System and Dynesys System components are intended to treat scoliosis in skeletally immature children. 2. Spine fusion.

4.

fda.gov

fda.gov/media/157897/download

FDA Executive Summary

The Tether™ – Vertebral Body Tethering System is a non-fusion spinal device intended for treatment of idiopathic scoliosis. Anchors and vertebral body screws ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39768709/

Anterior Vertebral Body Tethering (AVBT) in the Treatment ...

The findings of this study seem to suggest that this technical variant of AVBT is effective in the correction of both axial and coronal ...

6.

fda.gov

fda.gov/media/187213/download?attachment

Vertebral Body Tethering System (H190005)

The purpose of this review is to provide the Pediatric Advisory Committee (PAC) with post- market safety data so the committee can advise the Food and Drug ...

7.

trials.arthritis.org

trials.arthritis.org/trials/NCT03506334

Anterior Vertebral Body Tethering (AVBT) Using Zimmer ...

The Researchers want to assess the short-term safety of Anterior Vertebral Body Tethering (AVBT) in skeletally immature subjects with moderate to severe ...