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Surgical Outcomes Using Variable Rod Diameters in the Treatment of Idiopathic Scoliosis

Primary Purpose

Scoliosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Spinal rod
Sponsored by
Shriners Hospitals for Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis focused on measuring Juvenile Scoliosis, Adolescent Scoliosis, Scoliosis Management, Spinal Fusion, Scoliosis instrumentation, Juvenile or Adolescent Idiopathic Scoliosis

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Juvenile or Adolescent Idiopathic Scoliosis
  • Anticipated spinal fusion surgery

Exclusion Criteria:

  • Individuals younger than 11 years and older than 18 years
  • Individuals with scoliosis carrying additional diagnoses of illness.

Sites / Locations

  • Shriners Hospitals for Children - Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Subjects in this arm will receive the 5.5mm stainless steel instrumentation rod.

Subjects in this arm will receive a 6.35mm stainless steel instrumentation rod.

Outcomes

Primary Outcome Measures

Radiographic measurements of curve angles and balance.

Secondary Outcome Measures

Scoliosis Research Society-30 (SRS-30) questionnaire

Full Information

First Posted
July 31, 2007
Last Updated
January 15, 2013
Sponsor
Shriners Hospitals for Children
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1. Study Identification

Unique Protocol Identification Number
NCT00510575
Brief Title
Surgical Outcomes Using Variable Rod Diameters in the Treatment of Idiopathic Scoliosis
Official Title
Surgical Outcomes Using Variable Rod Diameters in the Treatment of Idiopathic Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shriners Hospitals for Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
There are two rod sizes routinely used for the correction of juvenile and adolescent idiopathic scoliosis, 5.5mm and 6.35mm, typically stainless steel. Currently there is no scientific evidence supporting the superiority of one size rod relative to the other. This study will evaluate the amount of radiographic correction obtained using the 5.5mm versus the 6.35mm spinal instrumentation rods.
Detailed Description
For the correction of Juvenile and Adolescent idiopathic scoliosis, companies offer and surgeons use varying rod sizes not based on scientific evidence, but because of personal preference, availability and company loyalty. To date there has been no literature evaluating the benefit or harm of one rod size versus the other. Our dual-arm prospective study will evaluate the amount of radiographic correction obtained using the 5.5mm versus the 6.35mm stainless steel instrumentation rods. These are both standard rods used in the community for this particular procedure, thus no additional risk exists for the patient. The results of this study will help guide surgeons in their decision making process when faced with the multitude of options offered by implant manufactures. Comparison(s): 5.5mm stainless steel spinal rod versus 6.35mm stainless steel spinal rod for correction of juvenile and idiopathic scoliosis curves.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
Keywords
Juvenile Scoliosis, Adolescent Scoliosis, Scoliosis Management, Spinal Fusion, Scoliosis instrumentation, Juvenile or Adolescent Idiopathic Scoliosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Subjects in this arm will receive the 5.5mm stainless steel instrumentation rod.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Subjects in this arm will receive a 6.35mm stainless steel instrumentation rod.
Intervention Type
Device
Intervention Name(s)
Spinal rod
Intervention Description
Posterior spinal fusion using a 5.5 or 6.35 size rod
Primary Outcome Measure Information:
Title
Radiographic measurements of curve angles and balance.
Time Frame
Pre-operatively, 6 wks post-op, 1 & 2 year post-op.
Secondary Outcome Measure Information:
Title
Scoliosis Research Society-30 (SRS-30) questionnaire
Time Frame
Pre-operatively, 6 wks post-op, 1 & 2 year post-op.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Juvenile or Adolescent Idiopathic Scoliosis Anticipated spinal fusion surgery Exclusion Criteria: Individuals younger than 11 years and older than 18 years Individuals with scoliosis carrying additional diagnoses of illness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norman Otsuka, MD
Organizational Affiliation
Shriners Hospitals for Children - Los Angeles
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Richard Bowen, MD
Organizational Affiliation
Shriners Hospitals for Children - Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shriners Hospitals for Children - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90020
Country
United States

12. IPD Sharing Statement

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Surgical Outcomes Using Variable Rod Diameters in the Treatment of Idiopathic Scoliosis

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