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Limited-efficacy Testing of SDS and NEMOST for Early Onset Neuromuscular Scoliosis

NCT04021784 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-06-05

No results posted yet for this study

Summary

The primary aim of this study is to investigate and describe the limited efficacy of the Spring Distraction System (SDS) and Bilateral One Way Rod (NEMOST) in maintaining curve reduction without repeat lengthening procedures and complications.

Secondary aims are to describe growth of the instrumented spine, health-related quality of life, and to compare both devices.

Conditions

  • Neuromuscular Scoliosis
  • Distraction System
  • Growth Friendly System

Interventions

DEVICE

SDS

The patient is implanted with SDS.

DEVICE

NEMOST

The patient is implanted with NEMOST.

Sponsors & Collaborators

  • EUROS

    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

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-06
Primary Completion
2023-03-13
Completion
2023-03-13

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 NCT04021784 on ClinicalTrials.gov