The Tether™ - Vertebral Body Tethering System Post Approval Study

Description

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.

Conditions

Scoliosis Idiopathic

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

The Tether™ - Vertebral Body Tethering System Post Approval Study

The Tether™ - Vertebral Body Tethering System Post Approval Study

Condition
Scoliosis Idiopathic
Intervention / Treatment

-

Contacts and Locations

San Diego

Rady Children's Hospital, San Diego, California, United States, 92123

Aurora

Children's Hospital Colorado, Aurora, Colorado, United States, 80045

Jacksonville

Nemours Children's Health, Jacksonville, Florida, United States, 32207

Atlanta

Children's Healthcare of Atlanta, Atlanta, Georgia, United States, 30342

New Orleans

Ochsner Health, New Orleans, Louisiana, United States, 70121

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Columbia

University of Missouri - Columbia, Columbia, Missouri, United States, 65201

New York

Mount Sinai, New York, New York, United States, 10029

Philadelphia

Shriners Children's Hopital, Philadelphia, Pennsylvania, United States, 19140

Seattle

Seattle Children's, Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * Presence of any systemic infection, local infection, or skin compromise at the surgical site
  • * Prior spinal surgery at the level(s) to be treated
  • * Documented poor bone quality, defined as a T-score -1.5 or less
  • * Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions
  • * Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent
  • * Unwillingness to sign Informed Consent Form and participate in study procedures

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

ZimVie,

Study Record Dates

2027-12-31