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

Primary Purpose

Scoliosis

Status
Withdrawn
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
titanium rod
ultra strength stainless steel rod
Sponsored by
Queen's University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Scoliosis focused on measuring scoliosis correction rod strength adolescent

Eligibility Criteria

10 Years - 20 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Queen's Univeristy

Outcomes

Primary Outcome Measures

percent correction in both frontal and sagittal planes for idiopathic scoliosis

Secondary Outcome Measures

screw purchase

Full Information

First Posted
October 7, 2008
Last Updated
August 26, 2019
Sponsor
Queen's University
Collaborators
DePuy Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT00768313
Brief Title
Phase IV Comparing Rods of Yield Strengths to Correct Adolescent Idiopathic Scoliosis.
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 Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Withdrawn
Why Stopped
lack of enrollment
Study Start Date
September 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
DePuy Orthopaedics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
Keywords
scoliosis correction rod strength adolescent

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
titanium rod
Intervention Description
comparison of rods of varying yield strengths and their ability to hold correction of scoliosis.
Intervention Type
Device
Intervention Name(s)
ultra strength stainless steel rod
Other Intervention Name(s)
Expedium ultra strength stainless steel rod (220KSI).
Intervention Description
interventions involving rods of various strength to treat scoliosis
Primary Outcome Measure Information:
Title
percent correction in both frontal and sagittal planes for idiopathic scoliosis
Time Frame
pre-op, 3, 6, 12, 24 months
Secondary Outcome Measure Information:
Title
screw purchase
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Borschneck, MD
Organizational Affiliation
Queen's Univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's Univeristy
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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