MedTrace Logo

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

NCT01672749 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2024-03-20

No results posted yet for this study

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

Conditions

  • Early Onset Scoliosis

Interventions

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)

Sponsors & Collaborators

  • AO Innovation Translation Center

    lead OTHER

Principal Investigators

  • Jean Ouellet, MD · McGill University Health Science Centre, Montreal, Canada

Eligibility

Min Age
5 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2023-02-28
Completion
2025-02-28

Countries

  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

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 NCT01672749 on ClinicalTrials.gov