The Tether™ - Vertebral Body Tethering System Post Approval Study
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• Diagnosis of progressive idiopathic scoliosis
• Skeletally immature, based on both Risser (\<5) and Sanders (\<8) assessments
• Major Cobb angle ≥30° and ≤65°
• Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging
• Failed or intolerant to bracing
Locations
United States
California
Rady Children's Hospital
RECRUITING
San Diego
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Florida
Nemours Children's Health
ACTIVE_NOT_RECRUITING
Jacksonville
Georgia
Children's Healthcare of Atlanta
RECRUITING
Atlanta
Louisiana
Ochsner Health
RECRUITING
New Orleans
Minnesota
Mayo Clinic
RECRUITING
Rochester
Missouri
University of Missouri - Columbia
RECRUITING
Columbia
New York
Mount Sinai
RECRUITING
New York
Pennsylvania
Shriners Children's Hopital
RECRUITING
Philadelphia
Washington
Seattle Children's
RECRUITING
Seattle
Contact Information
Primary
Monica Barascout, BS
Monica.Barascout@zimvie.com
1-303-465-8960
Backup
Kim Martinez
Kim.Martinez@zimvie.com
1-303-465-8960
Time Frame
Start Date: 2020-10-29
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 200
Treatments
Tether
Patients who have received The Tether HUD for treatment of idiopathic scoliosis.
Related Therapeutic Areas
Sponsors
Collaborators: Setting Scoliosis Straight Foundation, Exponent, Inc.
Leads: ZimVie