Trials / Unknown
UnknownNCT02897453
Safety and Efficacy Study of Spinal Tethering
Retrospective Review With Prospective Surveillance of Safety and Efficacy in a Clinical Series of Spinal Tethering Patients
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 56 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 10 Years – 23 Years
- Healthy volunteers
- Accepted
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).
Detailed description
Participants in this study will have already been implanted with a vertebral body tethering device. Patients will be recruited for prospective follow-up to enable systematic data capture from the point of study entry to their 18th birth year and skeletal maturity. Over the course of their follow-up clinical outcomes, patient reported outcomes, and radiographic outcomes will be tracked.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | The Spinal Tethering System | An implant comprised of: vertebral body screws, vertebral body staples (washers), and a PET (polyethylene-terephthalate) cord. |
Timeline
- Start date
- 2016-07-06
- Primary completion
- 2020-07-19
- Completion
- 2022-10-01
- First posted
- 2016-09-13
- Last updated
- 2020-08-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02897453. Inclusion in this directory is not an endorsement.