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Spinal Tethering

AVBT vs Spine Fusion for Scoliosis

Q: Is this research being conducted with current participants?

Correct. Clinicaltrials.gov's data indicates that this clinical trial, which was first posted on April 25th 2018, is actively recruiting. Approximately 80 patients need to be sourced from 1 medical centre.

Q: Am I eligible to take part in this experiment?

This investigation is seeking 80 minors aged 10 to 16 with <a href="https://www.withpower.com/clinical-trials/scoliosis">scoliosis</a>. These potential participants must be diagnosed with adolescent idiopathic scoliosis, have a curve between 40-70 degrees and possess at least 1 year of growth remaining as measured by Sanders bone age 4 or less/Risser stage 2 or lower. Additionally, their guardians should comprehend the study and sign applicable documents while providing appropriate assent for their child; finally, they need to guarantee that <a href="https://www.withpower.com/clinical-trials/all">all</a> visiting requirements are met including 3 months, one year and two years follow up visits.

Q: What is the maximum capacity for this research study?

Affirmative. According to the records held on clinicaltrials.gov, this medical experiment is presently seeking participants; it was posted in April 2018 and last amended June 2022. The trial requires 80 volunteers at a single site of enrolment.

Q: Is there an age minimum for individuals to partake in this research?

As indicated by the eligibility requirements, persons aged 10 to 16 are invited to apply for this clinical trial.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Revision spine surgery within 2 years of index procedure

Secondary outcome measures

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

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,205 Previous Clinical Trials

3,766,704 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.

Media Library

AVBT using Dynesys System Components (Spinal Tethering) Clinical Trial Eligibility Overview. Trial Name: NCT03506334 — N/A

Scoliosis Research Study Groups: Pediatric Scoliosis Patients, Pediatric Scoliosis Control Patients

Scoliosis Clinical Trial 2023: AVBT using Dynesys System Components Highlights & Side Effects. Trial Name: NCT03506334 — N/A

AVBT using Dynesys System Components (Spinal Tethering) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03506334 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research being conducted with current participants?

"Correct. Clinicaltrials.gov's data indicates that this clinical trial, which was first posted on April 25th 2018, is actively recruiting. Approximately 80 patients need to be sourced from 1 medical centre."

Answered by AI

Am I eligible to take part in this experiment?

"This investigation is seeking 80 minors aged 10 to 16 with scoliosis. These potential participants must be diagnosed with adolescent idiopathic scoliosis, have a curve between 40-70 degrees and possess at least 1 year of growth remaining as measured by Sanders bone age 4 or less/Risser stage 2 or lower. Additionally, their guardians should comprehend the study and sign applicable documents while providing appropriate assent for their child; finally, they need to guarantee that all visiting requirements are met including 3 months, one year and two years follow up visits."

Answered by AI

What is the maximum capacity for this research study?

"Affirmative. According to the records held on clinicaltrials.gov, this medical experiment is presently seeking participants; it was posted in April 2018 and last amended June 2022. The trial requires 80 volunteers at a single site of enrolment."

Answered by AI