R-FIX (Rib-FIXation System) for Severe Progressive Spinal Deformity: I-Corps Supplement

Project Summary Spinal deformity is a challenging clinical problem. Curvature can be in the lateral direction (scoliosis), anterior direction (hyperkyphosis) or both (kyphoscoliosis). Early-onset spinal deformity (EOSD) is deformity that begins before 10 years of age. Surgical correction typically involves aligning the spine with rods and pedicles screws. Unfortunately, patients undergoing surgery for spinal deformity experience high instrumentation-related complication rates, which negatively impact outcomes and limit deformity correction, especially in cases that involve EOSD or adult hyperkyphosis. Some of these complications include loss of proximal fixation (pedicle screw pull-out), rod breakage, proximal junctional kyphosis (PJK), and neurologic injury. This application proposes a new technique called the rib construct for correcting spinal deformity, especially in cases that involve EOSD or severe adult hyperkyphosis. Instead of anchoring rods to the spine with pedicle screws, the rib construct moves proximal fixation to the ribs using a series of hooks. This approach is a conceptual shift in approaching spinal deformity, in that the thorax is manipulated to secondarily reposition the spine. The rib construct allows the surgeon to manipulate the thorax in any combination of sagittal, coronal, and axial planes, allowing for safer, more effective, and versatile deformity correction. Rib fixation with the rib construct can be achieved with either: 1) off-label laminar hooks, which are already commercially available for spinal fixation to the lamina but can also be used on the ribs, or 2) rib hooks as part of our novel patented R-FIX (Rib-FIXation System). While laminar hooks have performed favorably compared to pedicle screws in our preliminary clinical use, these have been used entirely off-label and there is no commercially available surgical system designed for this technique. There have been issues with loss of fixation under torsional forces, implant prominence, and occasional cases of rib fracture with laminar hooks. The R-FIX System, which originated from a bioengineering lab (one of the applicants' labs) at Clemson University and has been further developed by Apex Orthopaedic Technologies, is designed to resolve these issues. The objective of this parent SBIR award is threefold: 1) to complete the design and manufacturing of the R-FIX System, 2) to prove the overall concept of rib fixation with the rib construct by obtaining basic science data to support the clinical data we have already obtained, and 3) to demonstrate the superior performance of R-FIX rib hooks compared to laminar hooks. Our group seeks to join the I-Corps Program to gain input from industry leaders on topics including regulatory strategy, IP strategy, end user needs, manufacturing, and sales. The business plan formulated during the I-Corp Program will be used in an SBIR Phase II submission in September 2023. Participation in this I-Corp Program would have the added benefit of providing a promising young MD-PhD candidate and prospective orthopedic surgeon, as well as an up-and- coming neurosurgeon, with additional training in the translational aspects of medical device development. Each member of this team is enthusiastic about participation in the I-Corp Program.