R-FIX (Rib-FIXation) Spinal Growth System for Early-onset Spinal Deformity

Project Summary Early-onset spinal deformity is a subset of pediatric spinal deformity that begins before the age of 10 years. Unlike adolescent idiopathic scoliosis, it is a life-threatening disease, which makes early intervention crucial. Surgical intervention must accommodate the growth of the developing spine, making this one of the most challenging orthopedic conditions to treat. Current intra-spinal based treatments, such as growing rods with pedicle screw fixation, have high complication rates and limited effectiveness. The R-FIX (Rib-FIXation) Spinal Growth System is an alternative extra-spinal technique that uses rib-based fixation for correcting early-onset spinal deformity. This extra-spinal rib fixation is a paradigm shift from seeking correction of the spine to emphasizing correction of thorax malalignment. The R-FIX System originated from a bioengineering lab (one of the applicants' labs) at Clemson University and has been further developed by Apex Orthopaedic Technologies. The R-FIX Spinal Growth System has been granted breakthrough device designation by the FDA. The objective of this SBIR Phase II award is threefold: 1) complete the final design, manufacturing, and quality control processes for the new R-FIX System components, 2) obtain the necessary biomechanical, biocompatibility, and sterility data resulting in successful 510(k) clearance of the R-FIX System, and 3) demonstrate the safety and efficacy of new R-FIX uni-axial rib hook and rib band designs in an animal model. This research will be conducted over 24 months and the data obtained from this grant proposal will result in a 510(k) application for FDA clearance and follow-up NIAMS pediatric medical device initiative clinical trial application. Major milestones to be achieved with this grant include 1) validation of new implantable R-FIX components with surgeon feedback, 2) completion of benchtop performance testing and FDA 510(k) submission, and 3) assessment of the safety and efficacy of new R-FIX components compared to pedicle screws in a pediatric hyperkyphosis porcine animal model.