Feasibility of Non-surgical Implant Adjustment

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DESCRIPTION (provided by applicant): While minimally invasive surgery has transformed the practice of surgery, access to implants for removal or alteration still requires surgery which generates risk and high cost. A next-generation approach is non-invasive, where implants are adjusted without an incision. There are clear applications in all fields of surgery, but particulary in orthopaedics where implants require frequent adjustment. One condition, early onset scoliosis, is disproportionally responsible for high cost and poor patient outcomes. Scoliosis, a pathological lateral curvature of the spine greater than 10, affects 2-4% of the population, or an estimated 6 million people in the United States. If left untreated, early onset scoliosis can cause damaging spinal deformity early in life; thus affecting other aspects of the child's health. There s no known cure for early onset idiopathic scoliosis. The most common surgical treatment of early onset scoliosis utilizes growing rods. In this procedure, rods are lengthened at 6 month intervals to maintain correction and control of the spinal deformity and to accommodate and facilitate spinal / thoracic growth without fusion. Studies have reported the mean age of the child at surgery to be 4.5 years with a mean number of procedures per patient was 9.3. The proposed novel technology performs essentially the same function as existing technology (growing rods). However, whereas the existing treatment requires invasive surgery every 6 months to access and tighten the set screw by a screwdriver, the Apto device adjusts the set screws non-invasively using a rotating magnet. The result of this non-invasive adjustment is transformational - the ability to lengthen the construct without surgery. This has the clear potential to both significantly improve patient outcomes and to significantly decrease healthcare costs. To the 6-year old (and his/her parents) recently diagnosed with early onset scoliosis, the prospect of facing surgery every six months for his/her entire childhood is daunting. The proposed solution promises to give these pediatric patients a childhood filled with learning, activity, and fun - not constant recovery or preparation for spinal surgery. Our long-term goal is to commercialize non-invasively adjustable implants, which have the potential to provide superior outcomes while reducing the cost of care. The objective of this proposal is to demonstrate the feasibility of non-invasively adjusting the length of growing rods for the application of early onset scoliosis. We plan to achieve our proposal's overall goals by addressing the following three specific aims: 1) Demonstrate the biocompatibility of the device; 2) Demonstrate the feasibility of implantation of the device in a living animal; and 3) Demonstrate the feasibility of non-invasive lengthening of growing rods at 2 time points. Completion of this proposal would demonstrate the feasibility of non-invasive adjustment of an orthopaedic implant.