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Phase IV Comparing Rods of Yield Strengths to Correct Adolescent Idiopathic Scoliosis.

NCT00768313 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-08-28

No results posted yet for this study

Summary

There has been a growing trend amongst surgeons to use a construct for correction of scoliosis which involves segmental instrumentation with pedicle screws. Pedicle screw proponents cite greater curve control in all planes, which results in improved spinal curve correction. Some surgeons have noted due to the increased strength of the all screw construction that the rod is now the weak part of the spinal fixation. Although no evidence has been raised in regards to hardware failure there is a perception that a loss of balance in the sagittal plane is the result of flex in the titanium rod. A novel solution to the issue of rod flexibility is raised with the expedium super steel instrumentation which allows for greater stiffness than a 5.5 mm titanium rod with the same lower profile. This study aims to compare the new super steel technology with other established instrumentations used to correct spinal stenosis.

Conditions

  • Scoliosis

Interventions

DEVICE

titanium rod

comparison of rods of varying yield strengths and their ability to hold correction of scoliosis.

DEVICE

ultra strength stainless steel rod

interventions involving rods of various strength to treat scoliosis

Sponsors & Collaborators

  • DePuy Orthopaedics

    collaborator INDUSTRY

  • Queen's University

    lead OTHER

Principal Investigators

  • Daniel Borschneck, MD · Queen's Univeristy

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE

Eligibility

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

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • Canada

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 NCT00768313 on ClinicalTrials.gov