Safety and Efficacy Study of Spinal Tethering
NCT02897453 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 56
Last updated 2020-08-20
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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