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The Tether™ - Vertebral Body Tethering System Post Approval Study
Sponsor: ZimVie
Summary
This study is an opportunity to provide continued reasonable assurance of the safety and probable benefit of The Tether HUD. The study will collect long term safety and efficacy information from patients who have had their idiopathic scoliosis treated via anterior vertebral body tethering (AVBT) with The Tether.
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2020-10-29
Completion Date
2027-12-31
Last Updated
2024-02-22
Healthy Volunteers
No
Conditions
Interventions
Anterior Vertebral Body Tethering
Anterior Vertebral Body Tethering (AVBT) is a technique that utilizes growth modulation to remodel the shape of the vertebra and straighten scoliotic curves in skeletally immature individuals. In this technique, screws are inserted at each vertebral level for the length of the convex side of the curve. A strong cord is connected through the screw tulip heads and used to initially straighten the curve as each level is fixed with a set screw. Following surgery and during the growth period the spine begins to remodel according to the Hueter-Volkmann Law, bone growth is relatively inhibited in areas of increased pressure (convex or tethered side) and relatively stimulated in areas of decreased pressure or tension (concave side).
Locations (10)
Rady Children's Hospital
San Diego, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Nemours Children's Health
Jacksonville, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Ochsner Health
New Orleans, Louisiana, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Missouri - Columbia
Columbia, Missouri, United States
Mount Sinai
New York, New York, United States
Shriners Children's Hopital
Philadelphia, Pennsylvania, United States
Seattle Children's
Seattle, Washington, United States