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.

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00768313

Enrollment

Registered

2008-10-08

Start date

2008-09-30

Completion date

2010-04-30

Last updated

2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis

Keywords

scoliosis correction rod strength adolescent

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screw purchase was to be recorded but study has been withdrawn.

Interventions

DEVICEtitanium rod

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

DEVICEultra strength stainless steel rod

interventions involving rods of various strength to treat scoliosis

Study design

Allocation

RANDOMIZED

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

10 Years to 20 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
percent correction in both frontal and sagittal planes for idiopathic scoliosis	pre-op, 3, 6, 12, 24 months

Secondary

Measure	Time frame
screw purchase	intraoperative

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026