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| Sponsored by: |
Shriners Hospitals for Children |
| Information provided by: | Shriners Hospitals for Children |
| ClinicalTrials.gov Identifier: | NCT00510575 |
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 IV |
| MedlinePlus related topics: | Scoliosis |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Surgical Outcomes Using Variable Rod Diameters in the Treatment of Idiopathic Scoliosis |
| Estimated Enrollment: | 300 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | May 2010 |
| Arms | Assigned Interventions |
|
1: Active Comparator
Subjects in this arm will receive the 5.5mm stainless steel instrumentation rod.
|
Device: Spinal rod |
|
2: Active Comparator
Subjects in this arm will receive a 6.35mm stainless steel instrumentation rod.
|
Device: Spinal rod |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Terri A Green, BS | 213-368-3326 | tgreen@shrinenet.org |
| Contact: Richard Bowen, MD | 213-388-3151 | rbowen@shrinenet.org |
| United States, California | |||||
| Shriners Hospitals for Children - Los Angeles | Recruiting | ||||
| Los Angeles, California, United States, 90020 | |||||
| Contact: Terri A Green, BS 213-368-3326 tgreen@shrinenet.org | |||||
| Contact: Richard Bowen, MD 213-388-3151 rbowen@shrinenet.org | |||||
| Principal Investigator: Richard Bowen, MD | |||||
| Shriners Hospitals for Children |
| Study Director: | Colin F Moseley, MD | Shriners Hospitals for Children - Los Angeles |
| Principal Investigator: | Richard Bowen, MD | Shriners Hospitals for Children - Los Angeles |
More Information
| Study ID Numbers: | SHCLA-0123 |
| First Received: | July 31, 2007 |
| Last Updated: | August 1, 2007 |
| ClinicalTrials.gov Identifier: | NCT00510575 |
| Health Authority: | United States: Institutional Review Board |
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