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.
