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

NCT ID: NCT00510575

Last Updated: 2013-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-01-31

Brief Summary

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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

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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.

Conditions

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Scoliosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

Spinal rod

Intervention Type DEVICE

Posterior spinal fusion using a 5.5 or 6.35 size rod

2

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

Group Type ACTIVE_COMPARATOR

Spinal rod

Intervention Type DEVICE

Posterior spinal fusion using a 5.5 or 6.35 size rod

Interventions

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Spinal rod

Posterior spinal fusion using a 5.5 or 6.35 size rod

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shriners Hospitals for Children

OTHER

Sponsor Role lead

Responsible Party

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Terri Green

Clinical Data Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Norman Otsuka, MD

Role: STUDY_DIRECTOR

Shriners Hospitals for Children - Los Angeles

Richard Bowen, MD

Role: PRINCIPAL_INVESTIGATOR

Shriners Hospitals for Children - Los Angeles

Locations

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Shriners Hospitals for Children - Los Angeles

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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SHCLA-0123

Identifier Type: -

Identifier Source: org_study_id

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