3-D Correction of Adolescent Idiopathic Scoliosis (AIS) With Differential Metals (AIS)
Juvenile and Adolescent Idiopathic Scoliosis
About this trial
This is an interventional treatment trial for Juvenile and Adolescent Idiopathic Scoliosis
Eligibility Criteria
Inclusion Criteria: Diagnosis of adolescent idiopathic scoliosis. Qualified patients will be confirmed for inclusion by patient history and radiographic studies Lenke Classification Curve type 1, 2, or 3. Willing and able to comply with the requirements of the protocol including follow-up requirements Willing and able to sign a study specific informed consent Skeletally mature (Risser grade III or higher, closed tri-radiate cartilage) between the ages of 10 and 18 years of age Exclusion Criteria: Previous spine surgery Previous posterior spine surgery (e.g., posterior decompression) that destabilizes the lumbar spine Active systemic infection or infection at the operative site Co-morbid medical conditions of the spine or upper/lower extremities that may affect the lumbar spine neurological and/or pain assessment Metabolic bone disease such as osteoporosis and osteopenia that contraindicates spinal surgery History of an osteoporotic fracture History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism Taking medications that may interfere with bony/soft tissue healing including chronic steroid use Known allergy to titanium or cobalt chrome Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C, or fibromyalgia Insulin-dependent type 1 or type 2 diabetes Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion Pregnant, or intends to become pregnant, during the course of the study Severe 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 sought Incarcerated at the time of study enrollment Current participation in an investigational study that may impact study outcomes Lenke Classification Curve Type 4, 5, or 6.
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
Prospective Range Spinal System
Retrospective
Adolescent (between the ages of 10-18 years of age), with Idiopathic Scoliosis Range Spinal System: rod contour changes utilizing Differential Rod Bending and pre-operative templating in Adolescent Idiopathic Scoliosis: A pilot study. The prospective arm consented subjects will use the Rod Counour measurement system
Retrospective matched cohort of subjects from the investigating surgeon are subjects that have not used the Rod contour measurement system. There is no intervention because the second arm is retrospective chart review.