NCT00510575

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2007

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

3.7 years

First QC Date

July 31, 2007

Last Update Submit

January 15, 2013

Conditions

Scoliosis

Keywords

Juvenile ScoliosisAdolescent ScoliosisScoliosis ManagementSpinal FusionScoliosis instrumentationJuvenile or Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

  • Radiographic measurements of curve angles and balance.

    Pre-operatively, 6 wks post-op, 1 & 2 year post-op.

Secondary Outcomes (1)

  • Scoliosis Research Society-30 (SRS-30) questionnaire

    Pre-operatively, 6 wks post-op, 1 & 2 year post-op.

Study Arms (2)

1

ACTIVE COMPARATOR

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

Device: Spinal rod

2

ACTIVE COMPARATOR

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

Device: Spinal rod

Interventions

Spinal rodDEVICE

Posterior spinal fusion using a 5.5 or 6.35 size rod

12

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shriners Hospitals for Children - Los Angeles

Los Angeles, California, 90020, United States

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Norman Otsuka, MD

    Shriners Hospitals for Children - Los Angeles

    STUDY DIRECTOR

  • Richard Bowen, MD

    Shriners Hospitals for Children - Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Data Coordinator

Study Record Dates

First Submitted

July 31, 2007

First Posted

August 2, 2007

Study Start

May 1, 2007

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)