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

Scoliosis Clinical Trial

Official title:

A Multi-Centre Randomized Phase IV Clinical Trial Comparing Rods of Varying Yield Strengths and Their Ability to Hold Correction of Adolescent Idiopathic Scoliosis.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00768313
• Other study ID #: DB-012008
• Status: Withdrawn
• Phase: Phase 4
• Start date: September 2008
• Est. completion date: April 2010

Study information

• Verified date: August 2019
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

screw purchase was to be recorded but study has been withdrawn.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Scoliosis

Intervention

Device:
• titanium rod
comparison of rods of varying yield strengths and their ability to hold correction of scoliosis.
• ultra strength stainless steel rod
interventions involving rods of various strength to treat scoliosis

Locations

Country	Name	City	State
Canada	Queen's Univeristy	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	DePuy Orthopaedics

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percent correction in both frontal and sagittal planes for idiopathic scoliosis		pre-op, 3, 6, 12, 24 months
Secondary	screw purchase		intraoperative