Phase IV Comparing Rods of Yield Strengths to Correct Adolescent Idiopathic Scoliosis.
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ClinicalTrials.gov Identifier: NCT00768313
Recruitment Status :
(lack of enrollment)
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.
Condition or disease
Device: titanium rodDevice: ultra strength stainless steel rod
screw purchase was to be recorded but study has been withdrawn.
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Layout table for eligibility information
Ages Eligible for Study:
10 Years to 20 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
presenting with a progressive lenke type 1A, N; or
type idiopathic adolescent scoliosis measuring greater than 45 degree cobb angle
rigid scoliosis requiring a three column release or osteotomy;
patients that can not have pedicle screw instrumentation due to technical concerns