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

This study has been terminated.
(lack of enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00768313
First Posted: October 8, 2008
Last Update Posted: May 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Johnson & Johnson
DePuy Orthopaedics
Information provided by:
Queen's University
  Purpose
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 Intervention Phase
Scoliosis Device: titanium rod Device: ultra strength stainless steel rod Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • percent correction in both frontal and sagittal planes for idiopathic scoliosis [ Time Frame: pre-op, 3, 6, 12, 24 months ]

Secondary Outcome Measures:
  • screw purchase [ Time Frame: intraoperative ]

Enrollment: 0
Study Start Date: September 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Device: titanium rod
comparison of rods of varying yield strengths and their ability to hold correction of scoliosis.
Experimental: 2 Device: ultra strength stainless steel rod
interventions involving rods of various strength to treat scoliosis
Other Name: Expedium ultra strength stainless steel rod (220KSI).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00768313


Locations
Canada, Ontario
Queen's Univeristy
Kingston, Ontario, Canada, K7L 3N6
Sponsors and Collaborators
Queen's University
Johnson & Johnson
DePuy Orthopaedics
Investigators
Principal Investigator: Daniel Borschneck, MD Queen's Univeristy
  More Information

Responsible Party: Dr. Daniel Borschneck, Queen's University
ClinicalTrials.gov Identifier: NCT00768313     History of Changes
Other Study ID Numbers: DB-012008
First Submitted: October 7, 2008
First Posted: October 8, 2008
Last Update Posted: May 17, 2010
Last Verified: May 2010

Keywords provided by Queen's University:
scoliosis correction rod strength adolescent

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases