Trials / Enrolling By Invitation
Enrolling By InvitationNCT03506334
Anterior Vertebral Body Tethering (AVBT) Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis
Prospective Pilot Study of Anterior Vertebral Body Tethering Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 10 Years – 16 Years
- Healthy volunteers
- Not accepted
Summary
The Researchers want to assess the short-term safety of Anterior Vertebral Body Tethering (AVBT) in skeletally immature subjects with moderate to severe scoliosis and compare them with a fusion cohort.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AVBT using Dynesys System Components | Zimmer Biomet Tether System and Dynesys System components are intended to treat scoliosis in skeletally immature children. |
| PROCEDURE | Spine fusion | Children with scoliosis undergoing fusion surgery will form the control arm |
Timeline
- Start date
- 2018-04-25
- Primary completion
- 2026-05-01
- Completion
- 2026-05-01
- First posted
- 2018-04-24
- Last updated
- 2025-06-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03506334. Inclusion in this directory is not an endorsement.