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

This study has been terminated.
(lack of enrollment)
Sponsor:
Collaborators:
Johnson & Johnson
DePuy Orthopaedics
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00768313
First received: October 7, 2008
Last updated: May 14, 2010
Last verified: May 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • screw purchase [ Time Frame: intraoperative ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   10 Years to 20 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Daniel Borschneck, Queen's University
ClinicalTrials.gov Identifier: NCT00768313     History of Changes
Other Study ID Numbers: DB-012008
Study First Received: October 7, 2008
Last Updated: May 14, 2010
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on October 23, 2014