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NCT Number: NCT00510575

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

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.

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Key information

Conditions

Scoliosis Bone Diseases Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shriners Hospitals for Children - Los Angeles

Los Angeles, California, 90020, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spinal rod

Device

Posterior spinal fusion using a 5.5 or 6.35 size rod

Primary outcomes

  1. Radiographic measurements of curve angles and balance.

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

Secondary outcomes

  1. Scoliosis Research Society-30 (SRS-30) questionnaire

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

Sponsors and collaborators

Lead sponsor

Shriners Hospitals for Children

Other

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Aug 2, 2007
Registry last updated
Jan 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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