Actively Recruiting
The Tether™ - Vertebral Body Tethering System Post Approval Study
Led by ZimVie · Updated on 2024-02-22
200
Participants Needed
10
Research Sites
374 weeks
Total Duration
On this page
Sponsors
Z
ZimVie
Lead Sponsor
S
Setting Scoliosis Straight Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Tether™ - Vertebral Body Tethering System Post Approval Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of progressive idiopathic scoliosis
- Skeletally immature based on Risser less than 5 and Sanders less than 8
- Major Cobb angle between 30 and 65 degrees
- Adequate bone structure to hold screws as shown by imaging
- Failed or could not tolerate bracing treatment
You will not qualify if you...
- Any systemic or local infection or skin issues at the surgical site
- Previous spinal surgery at the levels to be treated
- Poor bone quality with T-score of -1.5 or lower
- Medical or surgical conditions that prevent benefit from spinal surgery, such as blood clotting problems or allergies to implant materials
- Inability or unwillingness to follow post-operative care or attend follow-up visits
- Refusal to sign consent or participate in study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Rady Children's Hospital
San Diego, California, United States, 92123
Actively Recruiting
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Nemours Children's Health
Jacksonville, Florida, United States, 32207
Active, Not Recruiting
4
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30342
Actively Recruiting
5
Ochsner Health
New Orleans, Louisiana, United States, 70121
Actively Recruiting
6
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
7
University of Missouri - Columbia
Columbia, Missouri, United States, 65201
Actively Recruiting
8
Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
9
Shriners Children's Hopital
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
10
Seattle Children's
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
M
Monica Barascout, BS
CONTACT
K
Kim Martinez
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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