Comparison of Immune Response Following Posterior Spinal Fusion in Patients With Idiopathic vs. Neuromuscular Scoliosis

The primary endpoint is to evaluate serum immune profile assays obtained pre-operatively and post-operatively comparing patients with neuromuscular scoliosis to those with idiopathic scoliosis undergoing posterior spinal fusion. This will be done by obtaining a blood sample prior to incision in the operating room and one when the patient is in the PACU, prior to leaving. In the event that the patient is directly admitted to the pediatric intensive care unit (PICU), a sample will be obtained there. As part of standard of care, patients undergoing PSF have a peripheral arterial lane placed for intra-operative monitoring and blood draws. Samples drawn will determine serum immunophenotyping using cytokine profiles for the immune response testing. No investigational medications/devices or deviations from standard of care are required for study participation.

This will be an observational study in patients undergoing posterior spinal fusion. The anesthetic and surgical management of the patient will follow current standard of care, and the study design will not impact the current care of the patient. The study will enroll 10 patients with idiopathic scoliosis, and 10 patients with neuromuscular scoliosis. The primary endpoint of the study is to evaluate the immune response to posterior spinal fusion in patients with neuromuscular scoliosis, comparing them to patients with idiopathic scoliosis. Serum samples will be taken to evaluate serum immune profile assays. A secondary objective will be to compare and contrast the effect of transfusions (autologous and allogenic) on the immune response. Information will be collected from the EMR including sociodemographic data, clinical data, and intraoperative data.

As part of standard of care, patients undergoing posterior spinal fusion have a peripheral arterial line placed for intraoperative monitoring and blood draws. Prior to incision, a blood sample will be obtained that will determine immunophenotyping using cytokine profiles. NCH guidelines will be followed for total blood draw volumes for pediatric patients.

After the operation is complete and the patient is extubated after emergence from general anesthesia, the patient will move to the PACU. Prior to the patient leaving the PACU, the second sample would be obtained - serum immunophenotyping defined as the post-operative sample. In the event the patient is directly admitted to the PICU, a sample would be obtained in the PICU. In all cases, the sample will be collected by nurses or physicians and given to the research staff to complete the immune response testing.