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RECRUITING
NCT04505579

The Tether™ - Vertebral Body Tethering System Post Approval Study

Sponsor: ZimVie

View on ClinicalTrials.gov

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

Interventions

DEVICE

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