Study Stopped
lack of enrollment
Phase IV Comparing Rods of Yield Strengths to Correct Adolescent Idiopathic Scoliosis.
A Multi-Centre Randomized Phase IV Clinical Trial Comparing Rods of Varying Yield Strengths and Their Ability to Hold Correction of Adolescent Idiopathic Scoliosis.
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 7, 2008
CompletedFirst Posted
Study publicly available on registry
October 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedAugust 28, 2019
August 1, 2019
1.6 years
October 7, 2008
August 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
percent correction in both frontal and sagittal planes for idiopathic scoliosis
pre-op, 3, 6, 12, 24 months
Secondary Outcomes (1)
screw purchase
intraoperative
Interventions
comparison of rods of varying yield strengths and their ability to hold correction of scoliosis.
interventions involving rods of various strength to treat scoliosis
Eligibility Criteria
You may qualify if:
- aged 10-20;
- presenting with a progressive lenke type 1A, N; or
- type idiopathic adolescent scoliosis measuring greater than 45 degree cobb angle
You may not qualify if:
- rigid scoliosis requiring a three column release or osteotomy;
- patients that can not have pedicle screw instrumentation due to technical concerns
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Queen's Universitylead
- DePuy Orthopaedicscollaborator
Study Sites (1)
Queen's Univeristy
Kingston, Ontario, K7L 3N6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Borschneck, MD
Queen's Univeristy
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 7, 2008
First Posted
October 8, 2008
Study Start
September 1, 2008
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
August 28, 2019
Record last verified: 2019-08