Orthopaedic surgical procedures to correct axial and appendicular skeletal deformities are usually dependent upon fixation devices, either external or internal or both. These devices are often developed through close collaboration with engineers who are generally employed by major manufacturing companies. After the devices successfully clear rigorous bench, in-vitro, and in-vivo testing, the standard initial presentation of clinical results is a case series.
All too often the initial report of results comes from a co-developer of the device, with inherent selection and detection bias that constitute what most readers would consider a conflict of interest. McCarthy and McCullough’s case series on five-year results with Shilla growth guidance in 33 children with early-onset scoliosis in the October 7, 2015 JBJS is an exception to that rule. The authors report every conceivable major and minor adverse event without holding back any negative information. They categorize complications as infection secondary to wound breakdown, spinal alignment issues, and implant issues. The overall complication rate was 73%, a rate that is not surprising given the fact that the device under study is designed to maintain correction of spinal deformity in growing children.
Thankfully, the authors reported no neurologic complications. Also on the positive side, they found that spinal curves averaging 69° preoperatively averaged 38.4° at the most recent follow-up or prior to definitive spinal instrumentation. McCarthy and McCullough also calculated a 73% reduction in the number of surgical procedures among their cohort, relative to what would be necessary to treat the same population with distraction methods every six months.
I applaud the authors for comprehensively reporting the results of correction of spinal deformity in this difficult clinical situation with high accuracy and strict definitions of major and minor events. This is how we will make advances in correcting deformity for skeletally mature and immature patients—with innovation, incremental improvement, and the widespread sharing of adverse events with the orthopaedic community. Armed with the information from this study, we must now see what the number and severity of complications look like when the broader community of orthopaedic surgeons applies these devices.
Marc Swiontkowski, MD