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Limited-efficacy Testing of Spring Distraction System (SDS) and Unilateral One-way Rod (MID-C) for Early Onset Scoliosis

NCT04003233 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-03-23

No results posted yet for this study

Summary

The primary aim of this study is to investigate the limited efficacy of these innovative surgical solutions in treatment of Early Onset Scoliosis (EOS) in terms of maintaining reduction while maintaining spinal growth. The secondary aim is to compare both devices for these and other parameters as well as safety.

Conditions

  • Early-Onset Scoliosis Deformity of Spine (Disorder)
  • Idiopathic Scoliosis

Interventions

DEVICE

SDS

The SDS will be added to a traditional growing rod (TGR) of 4.5 or 5.5mm.

DEVICE

MID-C

The MID-C system consists of a unilateral one-way ratchet rod that is connected to the spine with polyaxial connectors

Sponsors & Collaborators

  • Apifix

    collaborator INDUSTRY

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Moyo C Kruyt, MD, PhD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2022-07-01
Completion
2022-12-01

Countries

  • Netherlands

Study Locations

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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 NCT04003233 on ClinicalTrials.gov