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RECRUITING

The Tether™ - Vertebral Body Tethering System Post Approval Study

NCT04505579 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 200 participants
Start Date 2020-10-29
Est. Completion 2027-12-31

Sponsor

ZimVie

6 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04505579

The ClinicalTrials.gov registry entry for NCT04505579 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ZimVie, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04505579 reports 10 study locations spanning 10 distinct geographic areas — top geographies include California, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04505579?

The interventions under investigation include: Anterior Vertebral Body Tethering (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04505579?

This trial is sponsored by ZimVie, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial