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Spinal Tethering

AVBT vs Spine Fusion for Scoliosis

N/A

Waitlist Available

Led By A. Noelle Larson, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male & female, age 10 years to 16 years

At least 1 year of growth remaining measured by Sanders bone age 4 or less or Risser stage 2 or less

Must not have

Prior surgery for scoliosis treatment

Patients with active systemic infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the safety of a new scoliosis treatment (AVBT) to the current standard of care (fusion).

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include pain at the site of surgery, infection risks associated with any surgical procedure, possible allergic reactions to materials used in devices if unknown allergies exist, and complications related to spinal surgeries such as nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 10 and 16 years old.

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My bones are still growing, according to medical tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery for scoliosis.

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I currently have an active infection in my body.

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My scoliosis is due to a birth condition, muscle disorder, or specific syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Revision spine surgery within 2 years of index procedure

Secondary study objectives

Bone structure of spine

Curve progression no greater than 10 degrees at latest f/u after 1st erect postop film (Fusion arm)

Major cobb angle curve progression greater than 10 degrees and curve magnitude < 50 degrees at latest f/u after 1st erect postop film (Tether arm)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pediatric Scoliosis PatientsExperimental Treatment1 Intervention

Tether group

Group II: Pediatric Scoliosis Control PatientsActive Control1 Intervention

Fusion (control) group

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,343 Previous Clinical Trials

3,062,298 Total Patients Enrolled

7 Trials studying Scoliosis

5,590 Patients Enrolled for Scoliosis

A. Noelle Larson, MD4.25 ReviewsPrincipal Investigator - Mayo Clinic

Mayo Clinic

1 Previous Clinical Trials

300 Total Patients Enrolled

1Patient Review

Dr. Larson is zealous in her attempts to get surgeries done on children. She's been known to make malicious referrals to CPS in order to get her way. In my opinion, she's a monster. If you have no other choice but to use her services, make sure your child is an organ donor opt-out. I would not put anything past her.