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The Tether™ - Vertebral Body Tethering System Post Approval Study

NCT04505579 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-02-22

No results posted yet for this 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

  • Scoliosis Idiopathic

Interventions

DEVICE

Anterior Vertebral Body Tethering

Anterior Vertebral Body Tethering (AVBT) is a technique that utilizes growth modulation to remodel the shape of the vertebra and straighten scoliotic curves in skeletally immature individuals. In this technique, screws are inserted at each vertebral level for the length of the convex side of the curve. A strong cord is connected through the screw tulip heads and used to initially straighten the curve as each level is fixed with a set screw. Following surgery and during the growth period the spine begins to remodel according to the Hueter-Volkmann Law, bone growth is relatively inhibited in areas of increased pressure (convex or tethered side) and relatively stimulated in areas of decreased pressure or tension (concave side).

Sponsors & Collaborators

  • Setting Scoliosis Straight Foundation

    collaborator OTHER

  • Exponent, Inc.

    collaborator UNKNOWN

  • ZimVie

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-29
Primary Completion
2027-08-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04505579 on ClinicalTrials.gov