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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Terri Green, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT00510575
First received: July 31, 2007
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Scoliosis
 Device: Spinal rod
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surgical Outcomes Using Variable Rod Diameters in the Treatment of Idiopathic Scoliosis

Resource links provided by NLM:

MedlinePlus related topics: Scoliosis
U.S. FDA Resources

Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • Radiographic measurements of curve angles and balance. [ Time Frame: Pre-operatively, 6 wks post-op, 1 & 2 year post-op. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Scoliosis Research Society-30 (SRS-30) questionnaire [ Time Frame: Pre-operatively, 6 wks post-op, 1 & 2 year post-op. ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: May 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Subjects in this arm will receive the 5.5mm stainless steel instrumentation rod.
 Device: Spinal rod
Posterior spinal fusion using a 5.5 or 6.35 size rod
Active Comparator: 2
Subjects in this arm will receive a 6.35mm stainless steel instrumentation rod.
 Device: Spinal rod
Posterior spinal fusion using a 5.5 or 6.35 size rod

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.

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510575

Locations
United States, California
Shriners Hospitals for Children - Los Angeles
Los Angeles, California, United States, 90020
Sponsors and Collaborators
Shriners Hospitals for Children
Investigators
Study Director: Norman Otsuka, MD Shriners Hospitals for Children - Los Angeles
Principal Investigator: Richard Bowen, MD Shriners Hospitals for Children - Los Angeles
  More Information

No publications provided

Responsible Party: Terri Green, Clinical Data Coordinator, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00510575     History of Changes
Other Study ID Numbers: SHCLA-0123
Study First Received: July 31, 2007
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:
Juvenile Scoliosis
Adolescent Scoliosis
Scoliosis Management
 Spinal Fusion
Scoliosis instrumentation
Juvenile or Adolescent Idiopathic Scoliosis

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 16, 2013