The largest contributors to overall cost were implants (29%), intensive care unit and inpatient room costs (22%), operating room time (9.9%), and bone grafts (6%). There were three significant independent predictors of increased total cost: the surgical approach used, the number of pedicle screws placed, and the number of vertebral levels fused. This study characterizes the relative contributions of factors that contribute to total costs, charges, and reimbursements that can, in time, identify potential areas for cost reduction or redistribution of resources in the surgical treatment of adolescent idiopathic scoliosis.
Primary NM scoliosis and revision sagittal plane deformities appear to carry greatest incidence of NMCs during surgical intervention. Most observed NMCs did not result in a permanent neurologic deficit. Neuromonitoring should be assessed throughout the entire surgical procedure. This study may aid surgeons and patients to better assess neurologic risks related to spinal deformity surgery.
BackgroundThe purpose of this study was to determine the indications for implantation of the coflex device (Paradigm Spine, LLC, New York, New York), assess long-term complications, and evaluate the long-term clinical outcomes of patients.
MethodsA total of 127 patients underwent placement of a coflex implant for various indications by one orthopaedic spine surgeon. The mean follow-up was 6.3 years. The original indications for implantation were determined based upon the data provided in the case report forms. Preoperatively and postoperatively, patients were asked to grade their low-back and leg pain using the visual analog scale (VAS) and the pain severity scale: no pain (0), mild pain (1), moderate pain (2), or severe pain (3).Patients were queried about their satisfaction with the surgical procedure. Follow-up radiographs were taken to determine any device-related issues.
ResultsThe most prevalent diagnoses for implantation were spinal stenosis (19.7%) and spinal stenosis with lumbar disc herniation (35.4%). The mean severity of low-back pain was decreased by 33% (from moderate to mild) at the 2-year follow-up (P < .001) and at the 5-year follow-up (from moderate to mild, P < .001). The mean severity of leg pain was decreased by 66% (from severe to mild) at the 2-year follow-up (P < .001) and at the 5-year follow-up (from severe to mild, P < .001). At the mean follow-up period of 6.3 years, a patient satisfaction query demonstrated that 7% were unsatisfied, 46% were satisfied, and 46% were very satisfied with their clinical outcome. Based on the follow-up radiographs, 92 of patients had no devicerelated issues and 8% had device-related issues.
ConclusionThe data provided have demonstrated that the coflex implant provides pain relief for patients with low-back pain and leg pain. The most common indications for implantation were spinal stenosis and spinal stenosis with lumbar disc herniation. There were very few device-related complications.
Clinical SignificanceUsing coflex is a safe and viable option in the selection of instrumentation for spinal stabilization.
This study has shown that using the FlexiCore system at 1 and/or 2 intervertebral disc spaces caudal to a scoliosis fusion model did not significantly change the sensor deflection at the 2 segments adjacent to a scoliosis fusion construct. Future research will continue to define the clinical setting and patients best suited for management by TDR systems.
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