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NCT04505579 · ClinicalTrials.gov registry record
The Tether™ - Vertebral Body Tethering System Post Approval Study
A clinical trial of Scoliosis Idiopathic, sponsored by ZimVie.
- Recruiting
- Registry status
- 200
- Enrollment target
- 10
- Study locations
NCT04505579: Recruiting study of Scoliosis Idiopathic, sponsored by ZimVie.
NCT04505579 is a study of Scoliosis Idiopathic that is actively recruiting participants, run by ZimVie. The registered enrollment target is 200 participants, below the 264-participant average among 5 other Scoliosis Idiopathic trials with a reported enrollment target (24% lower). The trial reports 10 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04505579, a study of Scoliosis Idiopathic, is actively recruiting participants, sponsored by ZimVie.
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 10
- Study locations
Study 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.
Primary Outcome
The primary safety endpoint is the rate of Serious Adverse Events (SAEs) and device- and/or procedure-related Adverse Events (AEs)
Conditions Studied
Interventions
- DEVICE Anterior Vertebral Body Tethering
Study Locations (10)
California
- Rady Children's Hospital - San Diego
Colorado
- Children's Hospital Colorado - Aurora
Florida
- Nemours Children's Health - Jacksonville
Georgia
- Children's Healthcare of Atlanta - Atlanta
Louisiana
- Ochsner Health - New Orleans
Minnesota
- Mayo Clinic - Rochester
Missouri
- University of Missouri - Columbia - Columbia
New York
- Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2020-10-29 |
| Est. Completion | 2027-12-31 |
What NCT04505579 shows while recruiting
NCT04505579 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 264-participant average among 5 other Scoliosis Idiopathic trials with a reported enrollment target (24% lower).
The record links to 1 condition, with Scoliosis Idiopathic appearing as the primary indexed condition, and to 1 intervention - of which Anterior Vertebral Body Tethering is the first listed.
NCT04505579 lists 10 locations in 10 states (California, Colorado, Florida).
Frequently Asked Questions
What is clinical trial NCT04505579 about?
NCT04505579 is a clinical study titled "The Tether™ - Vertebral Body Tethering System Post Approval Study". 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) wit...
What is the current status of trial NCT04505579?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2020-10-29. Estimated completion is 2027-12-31.
What conditions does trial NCT04505579 study?
This clinical trial studies the following conditions: Scoliosis Idiopathic.
What interventions are being tested in trial NCT04505579?
The interventions under investigation include: Anterior Vertebral Body Tethering (DEVICE).
Who is sponsoring clinical trial NCT04505579?
This trial is sponsored by ZimVie, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04505579 being conducted?
This trial has 10 study locations across California, Colorado, Florida, Georgia, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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