Safety and Efficacy Study of Spinal Tethering

NCT02897453 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 56

Last updated 2020-08-20

No results posted yet for this study

Summary

This study is an opportunity to gather long term safety and efficacy information from patients who have had their scoliosis treated via anterior vertebral body tethering (VBT).

Conditions

  • Adolescent Idiopathic Scoliosis

Interventions

DEVICE

The Spinal Tethering System

An implant comprised of: vertebral body screws, vertebral body staples (washers), and a PET (polyethylene-terephthalate) cord.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Amer Samdani, MD · Shriners Hospitals for Children - Philadelphia

Eligibility

Min Age
10 Years
Max Age
23 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-06
Primary Completion
2020-07-19
Completion
2022-10-31

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 NCT02897453 on ClinicalTrials.gov