Anterior Vertebral Body Tethering (AVBT) Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis

Study Purpose

The Researchers want to assess the short-term safety of Anterior Vertebral Body Tethering (AVBT) in skeletally immature subjects with moderate to severe scoliosis and compare them with a fusion cohort.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 10 Years - 16 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male & female, age 10 years to 16 years. 2. Scoliosis curve between 40-70 degrees. 3. At least 1 year of growth remaining measured by Sanders bone age 4 or less or Risser stage 2 or less. 4. Adolescent idiopathic scoliosis. 5. Lenke 1, 2, 3C, 5 (thoracic, thoracolumbar, or thoracic and lumbar). 6. Parents must be able to understand the study and sign the consent document. Assent will be obtained and documented as age appropriate. 7. Patients and parents must be able to comply with study procedures and visits, including 3-month, 1-year, and 2-year follow-up visits.

Exclusion Criteria:

1. Congenital, neuromuscular or syndromic scoliosis. 2. Underlying neuromuscular disease. 3. Pregnancy. 4. Nonflexible curves (bending films show residual curve greater than 40 degrees). 5. Prior surgery for scoliosis treatment. 6. Patients with active systemic infection. 7. Known, reported allergies to titanium, PET, or PCU. Known, reported substance abuse, including alcohol.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03506334
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Mayo Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

A. Noelle Larson, MD
Principal Investigator Affiliation Mayo Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Scoliosis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Pediatric Scoliosis Patients

Tether group

Active Comparator: Pediatric Scoliosis Control Patients

Fusion (control) group

Interventions

Device: - AVBT using Dynesys System Components

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

Procedure: - Spine fusion

Children with scoliosis undergoing fusion surgery will form the control arm

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905