3-D Correction of Adolescent Idiopathic Scoliosis (AIS) With Differential Metals

This study is designed to evaluate the coronal, sagittal, and axial correction of deformity secondary to adolescent idiopathic scoliosis utilizing a technique employing a posterior spinal fusion construct utilizing rods of different material rigidity and asymmetric bends determined using computer-based software to pre-operatively template a best-fit rod contour from pre-operative radiographs. To further evaluate the changes in contour of the rods from the pre-operative templates to the post-implantation radiographs.

Inclusion Criteria:Diagnosis of adolescent idiopathic scoliosis. Qualified patients will be confirmed for inclusion by patient history and radiographic studiesLenke Classification Curve type 1, 2, or 3.Willing and able to comply with the requirements of the protocol including follow-up requirementsWilling and able to sign a study specific informed consentSkeletally mature (Risser grade III or higher, closed tri-radiate cartilage) between the ages of 10 and 18 years of ageExclusion Criteria:Previous spine surgeryPrevious posterior spine surgery (e.g., posterior decompression) that destabilizes the lumbar spineActive systemic infection or infection at the operative siteCo-morbid medical conditions of the spine or upper/lower extremities that may affect the lumbar spine neurological and/or pain assessmentMetabolic bone disease such as osteoporosis and osteopenia that contraindicates spinal surgeryHistory of an osteoporotic fractureHistory of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolismTaking medications that may interfere with bony/soft tissue healing including chronic steroid useKnown allergy to titanium or cobalt chromeRheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C, or fibromyalgiaInsulin-dependent type 1 or type 2 diabetesMedical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completionPregnant, or intends to become pregnant, during the course of the studySevere obesity (Body Mass Index > 40)Physical or mental condition (e.g., psychiatric disorder, dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain, or quality of life.Involved in current or pending spinal litigation where permanent disability benefits are being soughtIncarcerated at the time of study enrollmentCurrent participation in an investigational study that may impact study outcomesLenke Classification Curve Type 4, 5, or 6.