Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

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

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. Identifier: NCT00768313
Recruitment Status : Withdrawn (lack of enrollment)
First Posted : October 8, 2008
Last Update Posted : August 28, 2019
DePuy Orthopaedics
Information provided by (Responsible Party):
Dr. Daniel Borschneck, Queen's University

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.

Condition or disease Intervention/treatment Phase
Scoliosis Device: titanium rod Device: ultra strength stainless steel rod Phase 4

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screw purchase was to be recorded but study has been withdrawn.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Masking: Single (Participant)
Primary Purpose: Other
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.
Study Start Date : September 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Intervention Details:
  • Device: titanium rod
    comparison of rods of varying yield strengths and their ability to hold correction of scoliosis.
  • Device: ultra strength stainless steel rod
    interventions involving rods of various strength to treat scoliosis
    Other Name: Expedium ultra strength stainless steel rod (220KSI).

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

Secondary Outcome Measures :
  1. screw purchase [ Time Frame: intraoperative ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   10 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00768313

Layout table for location information
Canada, Ontario
Queen's Univeristy
Kingston, Ontario, Canada, K7L 3N6
Sponsors and Collaborators
Queen's University
DePuy Orthopaedics
Layout table for investigator information
Principal Investigator: Daniel Borschneck, MD Queen's Univeristy

Layout table for additonal information
Responsible Party: Dr. Daniel Borschneck, Principal Investigator, Queen's University Identifier: NCT00768313    
Other Study ID Numbers: DB-012008
First Posted: October 8, 2008    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Keywords provided by Dr. Daniel Borschneck, Queen's University:
scoliosis correction rod strength adolescent
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases