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

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Scoliosis

Intervention / Treatment
-----------------
* Device: Spinal rod


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Subjects in this arm will receive the 5.5mm stainless steel instrumentation rod. | Device: Spinal rod<br>* Posterior spinal fusion using a 5.5 or 6.35 size rod<br>|
| Active Comparator: 2<br>Subjects in this arm will receive a 6.35mm stainless steel instrumentation rod. | Device: Spinal rod<br>* Posterior spinal fusion using a 5.5 or 6.35 size rod<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic measurements of curve angles and balance. |  | Pre-operatively, 6 wks post-op, 1 & 2 year post-op. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scoliosis Research Society-30 (SRS-30) questionnaire |  | Pre-operatively, 6 wks post-op, 1 & 2 year post-op. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Juvenile Scoliosis, Adolescent Scoliosis, Scoliosis Management, Spinal Fusion, Scoliosis instrumentation, Juvenile or Adolescent Idiopathic Scoliosis