The spine research program has focused on understanding the anatomy, biomechanics and biology of the spine and how this may be used to improve our scoliosis care. Development of innovative treatment methods, the mechanobiology of growth, the biomechanical function of spine ligaments and biomechanics of instrumentation insertion have been recently investigated.
A crucial difference between pediatric and adult orthopaedic biomechanics is growth. A new collaborative basic science research program between the Divisions of Orthopaedic Surgery and Developmental Biology on the regulation of the skeletal growth plates has been started at Cincinnati Children's. This program is designed to study physiological growth and, subsequently, patterns of abnormal growth as a result of changes to these regulatory pathways.
More than most other branches of medicine, mechanics is central to orthopaedics. Therefore, the mechanobiology of growth is a primary research interest, especially as it impacts the clinical treatment of skeletal deformities. We have designed and fabricated a spine staple based on the premise that some scoliosis may be surgically arrested or corrected much less invasively than with spinal fusion by modifying spine growth. The initial work was published in Spine (May 20, 2005). A company, SpineForm LLC, was created to develop, test and commercialize the spinal staple.
With the help of a Cincinnati Children's Trustee Grant in 1994, we began animal studies on endoscopic approaches to scoliosis correction. We initially validated that thoracoscopic discectomy improved spine flexibility as well as traditional discectomy in which the chest was split open (Spine, 1998).
More recently we defined the normal pressures exerted on the growth plate using novel microelectromechanical (MEMS) stress sensors that we fabricated in our lab in collaboration with the University of Cincinnati’s Micro / Nano Engineering group and support from grants from the trustees and Scoliosis Research Society.
We also quantified the structural features of spine growth plate tissues from scoliosis patients. With these tissues, we have determined that growth activity remains in the spine even in patients with severe deformities. In November 2009, the FDA conditionally approved its first pediatric orthopaedic investigational device exemption (IDE) for studying the SpineForm spine staple in children. This landmark IDE approval is also the first for a spine growth modulation device by any regulatory body in the world. Our next steps are to obtain national and international investigator agreements, site agreements and site IRB approvals.