RECRUITING

The Tether™ - Vertebral Body Tethering System Post Approval Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

The Tether™ - Vertebral Body Tethering System Post Approval Study

Quick Facts

Study Start:2020-10-29
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04505579

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of progressive idiopathic scoliosis
  2. * Skeletally immature, based on both Risser (\<5) and Sanders (\<8) assessments
  3. * Major Cobb angle ≥30° and ≤65°
  4. * Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging
  5. * Failed or intolerant to bracing
  1. * Presence of any systemic infection, local infection, or skin compromise at the surgical site
  2. * Prior spinal surgery at the level(s) to be treated
  3. * Documented poor bone quality, defined as a T-score -1.5 or less
  4. * 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
  5. * 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
  6. * Unwillingness to sign Informed Consent Form and participate in study procedures

Contacts and Locations

Study Contact

Monica Barascout, BS
CONTACT
1-303-465-8960
Monica.Barascout@zimvie.com
Kim Martinez
CONTACT
1-303-465-8960
Kim.Martinez@zimvie.com

Study Locations (Sites)

Rady Children's Hospital
San Diego, California, 92123
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Nemours Children's Health
Jacksonville, Florida, 32207
United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
United States
Ochsner Health
New Orleans, Louisiana, 70121
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
University of Missouri - Columbia
Columbia, Missouri, 65201
United States
Mount Sinai
New York, New York, 10029
United States
Shriners Children's Hopital
Philadelphia, Pennsylvania, 19140
United States
Seattle Children's
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: ZimVie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-29
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2020-10-29
Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Scoliosis Idiopathic