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

Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00510575
• Other study ID #: SHCLA-0123
• Status: Completed
• Phase: Phase 4
• First received: July 31, 2007
• Last updated: January 15, 2013
• Start date: May 2007
• Est. completion date: January 2011

Study information

• Verified date: January 2013
• Source: Shriners Hospitals for Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scoliosis

Intervention

Device:
• Spinal rod
Posterior spinal fusion using a 5.5 or 6.35 size rod

Locations

Country	Name	City	State
United States	Shriners Hospitals for Children - Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic measurements of curve angles and balance.		Pre-operatively, 6 wks post-op, 1 & 2 year post-op.	No
Secondary	Scoliosis Research Society-30 (SRS-30) questionnaire		Pre-operatively, 6 wks post-op, 1 & 2 year post-op.	No