NCT01672749

Evaluation of a Modern System to Allow for Growth in Children With Scoliosis Versus a Conventional Treatment

Evaluation of a Growth Guiding Construct vs. Standard Dual Growing Rods and VEPTR for the Treatment of Early Onset Scoliosis Patients: A Prospective Multi-center Cohort Study With a Matched Historical Control

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: AO Innovation Translation Center · Academic / Other
• Sex: All
• Age: 5 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

The foremost challenge when managing early onset scoliosis (curve deformity before the age of 10) is to prevent curve progression while maintaining growth of the spine. Current treatment options require repetitive interventions as the spine and the child grow. This study will compare two techniques of growth modulation: Standard dual growing rods versus the new Luqué Trolley screws Hypothesis: Patients treated with the DePuy Synthes TROLLEY system will undergo fewer re-operations after 3 years of follow-up (FU) than patients included in the comparison group

Detailed description

The purpose of this clinical study is to show that the growth guiding construct with DePuy Synthes TROLLEY Gliding Vehicles allows for less re-operations and for ongoing spinal growth across an instrumented immature spine while preventing curve progression in early onset scoliosis patients.

Conditions

• Early Onset Scoliosis

Interventions

Type	Name	Description
DEVICE	Growth guiding construct using TROLLEY system	Growth guiding construct using the DePuy Synthes TROLLEY Gliding Vehicles (GVs)
DEVICE	Spine based dual growing rod or rib based VEPTR	spine based dual growing rod or the rib based Vertical Expandable Prosthetic Titanium Rib (VEPTR, Synthes North America)

Timeline

• Start date: 2015-06-01
• Primary completion: 2023-02-01
• Completion: 2025-02-01
• First posted: 2012-08-27
• Last updated: 2024-03-20

Locations

3 sites across 2 countries: Switzerland, United Kingdom