The Tether™ - Vertebral Body Tethering System Post Approval Study

RecruitingOBSERVATIONAL
Enrollment

200

Participants

Timeline

Start Date

October 29, 2020

Primary Completion Date

August 31, 2027

Study Completion Date

December 31, 2027

Conditions
Scoliosis Idiopathic
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).

Trial Locations (10)

10029

RECRUITING

Mount Sinai, New York

19140

RECRUITING

Shriners Children's Hopital, Philadelphia

30342

RECRUITING

Children's Healthcare of Atlanta, Atlanta

32207

ACTIVE_NOT_RECRUITING

Nemours Children's Health, Jacksonville

55905

RECRUITING

Mayo Clinic, Rochester

65201

RECRUITING

University of Missouri - Columbia, Columbia

70121

RECRUITING

Ochsner Health, New Orleans

80045

RECRUITING

Children's Hospital Colorado, Aurora

92123

RECRUITING

Rady Children's Hospital, San Diego

98105

RECRUITING

Seattle Children's, Seattle

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Setting Scoliosis Straight Foundation

OTHER

collaborator

Exponent, Inc.

UNKNOWN

lead

ZimVie

INDUSTRY