- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00510575
Surgical Outcomes Using Variable Rod Diameters in the Treatment of Idiopathic Scoliosis
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
California
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Los Angeles, California, United States, 90020
- Shriners Hospitals for Children - Los Angeles
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Subjects in this arm will receive the 5.5mm stainless steel instrumentation 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.
|
Posterior spinal fusion using a 5.5 or 6.35 size rod
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Radiographic measurements of curve angles and balance.
Time Frame: Pre-operatively, 6 wks post-op, 1 & 2 year post-op.
|
Pre-operatively, 6 wks post-op, 1 & 2 year post-op.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Scoliosis Research Society-30 (SRS-30) questionnaire
Time Frame: Pre-operatively, 6 wks post-op, 1 & 2 year post-op.
|
Pre-operatively, 6 wks post-op, 1 & 2 year post-op.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Norman Otsuka, MD, Shriners Hospitals for Children - Los Angeles
- Principal Investigator: Richard Bowen, MD, Shriners Hospitals for Children - Los Angeles
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHCLA-0123
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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