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

NCT ID: NCT00768313

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-04-30

Brief 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.

Detailed Description

screw purchase was to be recorded but study has been withdrawn.

Conditions

Scoliosis

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Interventions

titanium rod

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

Intervention Type: DEVICE

ultra strength stainless steel rod

interventions involving rods of various strength to treat scoliosis

Intervention Type: DEVICE

Other Intervention Names

Expedium ultra strength stainless steel rod (220KSI).

Eligibility Criteria

Inclusion Criteria

• aged 10-20;
• presenting with a progressive lenke type 1A, N; or
• type idiopathic adolescent scoliosis measuring greater than 45 degree cobb angle

Exclusion Criteria

• rigid scoliosis requiring a three column release or osteotomy;
• patients that can not have pedicle screw instrumentation due to technical concerns

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Orthopaedics

INDUSTRY

Sponsor Role: collaborator

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Daniel Borschneck

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Borschneck, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's Univeristy

Locations

Queen's Univeristy

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

DB-012008

Identifier Type: -

Identifier Source: org_study_id