The purpose of this study is to assess the safety and usefulness of pedicle screws in children undergoing surgical treatment for spinal deformity.
What are Pedicle Screws and how are They Used in Surgery?
Pedicle screws are fixation screws that are placed through the pedicle of the vertebra to aid in spinal fusion surgery. The screws themselves do no fix the spine, but they anchor points along a long connecting rod. The screws are anchored at a few consecutive spine segments and then a rod is used to connect the screws together and straighten the spine. The rod and screws together prevent motion at the segments of the spine that are being fused. Bone graft is then added and the spine slowly fuses together in a straight line (guided by the screw-rod construct).
Who are Eligible?
Those eligible for the study are patients with a diagnosis of spinal deformity and are undergoing corrective spinal surgery utilizing pedicle screws. All prospective patients must be having surgery before the age of 20 years and 11 months. All retrospective patients must have had surgery within the last 12 months.
Study Procedures/Recruitment
As part of the standard of care, the patient's spinal curvature will be measured using routine procedures. No additional scans or x-rays will be administered to any study patients for research purposes.
Upon the decision to undergo spinal surgery for the patient's spinal deformity, eligible patients and their parents will be asked by their orthopaedic surgeon if they are willing to participate in this study. If they agree informed consent, assent, and HIPAA Clinical Research Authorization will be obtained by the treating physician and/or the research coordinator.
Purpose