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

Phase 4

Completed

• Conditions: Scoliosis
• Interventions: Device: Spinal rod

• Registration Number: NCT00510575
• Lead Sponsor: Shriners Hospitals for Children

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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-07-31
• Study First Submitted QC: 2007-08-01
• Study First Posted: 2007-08-02
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-15
• Last Update Posted: 2013-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Spinal rod	Subjects in this arm will receive the 5.5mm stainless steel instrumentation rod.
2	Spinal rod	Subjects in this arm will receive a 6.35mm stainless steel instrumentation rod.

Primary Outcome Measures

Name	Time	Method
Radiographic measurements of curve angles and balance.	Pre-operatively, 6 wks post-op, 1 & 2 year post-op.

Secondary Outcome Measures

Name	Time	Method
Scoliosis Research Society-30 (SRS-30) questionnaire	Pre-operatively, 6 wks post-op, 1 & 2 year post-op.

Trial Locations

Locations (1)

Shriners Hospitals for Children - Los Angeles; 🇺🇸 Los Angeles, California, United States