Abstract

In spinal deformity surgery, techniques and implants must be assessed for their safety and efficacy. Regulatory bodies, third-party payors, and patients will increasingly scrutinize treatment methods based on the frequency of adverse events. We therefore developed a classification of adverse hardware-related events using plain radiographic criteria. We analyzed the adverse events in 466 patients surgically treated for adolescent idiopathic scoliosis for a Type 1 (Lenke et al.) curve. We used plain radiographic films to define complications as either serious radiographic adverse events or radiographic adverse events in four technique groups: posterior spinal fusion with hooks and/or hybrid systems, posterior spinal fusion using mostly pedicle screws, open anterior spinal fusion, and thoracoscopic anterior spinal fusion. We defined serious radiographic adverse events as those requiring subsequent surgery. The minimum followup was 2 years. We found a reoperation rate ranging from 4.5% (open anterior spinal fusion) to 8.8% (posterior spinal fusion with hooks); we found no difference in the incidence of serious radiographic adverse events between surgical techniques. Among serious radiographic adverse events, the most common problems were revision for lumbar progression, rod breakage, and proximal screw pullout in the anterior spinal fusions and instrumentation removal for pain and infection in the posterior spinal fusions. We propose a new radiographic system of adverse hardware-related events for patients with Type 1 adolescent idiopathic scoliosis. Level III, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.

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