OSSEOSCREW SPINAL FIXATION SYSTEM
Introduction to the Osseoscrew Spinal Fixation System
The OsseoScrew pedicle screw spinal fixation system was designed to improve our ability to secure the spine in clinical conditions where the bone of the spine was compromised or weaker than normal such as in conditions like osteoporosis or cancer.
As a result of the fact people are living longer, conditions which occur as we age are becoming more common. Consequently, solid methods to address problems associated age related conditions are are needed to address these issues. Alphatec Spine, Inc out of Carlsbad, California recognized the need for “Solutions for the the Aging Spine” and sought to develop a better way to stabilize the vertebral bone in the spine. Prior to their effort, the most common technique used in spinal surgery was to anchor screws placed into the spine with acrylic polymers or glue such as polymethyl methacrylate or PMMA. PMMA usage resulted in longer surgery, technical difficulties getting the glue to form consistent uniform solid anchors for screws and could result in embolization into patients’ bloodstreams.
Concept and Development
One product which was developed specifically for osteoporosis was the OsseoScrew. Inspired by anchors used in the construction industry, developers sought to make a screw which would be expandable after it was placed into the bone which would thereby make it a better anchor. The concept was similar to what many people would recognize in sheet rock anchors used to hold items in relatively soft walls. The screw was conceptualized, built, tested in the laboratory and by 2009, OsseoScrew was identified to be one of the best new spinal technologies in the 2009 Orthopedics This Week Spine Technology Awards. Dr. Beer participated in the development of this product.
In the laboratory, OsseoScrew was shown to have nearly 30 % greater anchoring strength as compared to traditional pedicle screws which remain the most commonly used option for spinal stabilization today. This improvement in the “pull-out” strength was astonishing and a major advance for spinal stabilization. It was clear based on this testing these screws could address weakened bone problems which historically had limited less desirable options for treatment. Unfortunately, this testing alone in the laboratory was insufficient to gain approval to the use of this device in the United States.
Initial Use of The OsseoScrew
OsseoScrew was released early after its development and laboratory testing into the European market for use in patients in Europe. At the same time, Alphatec Spine, Inc, began testing and later trials to satisfy requirements set forth by the Food and Drug Association (FDA) in the United States. In Europe, the screws were found to result in excellent spinal fixation and remain available for use there today. In the United States, rigorous requirements set forth by the FDA stifled the release of the product and, in fact, the product was nearly abandoned as a result of the expenses related to securing FDA approval.
New Management ATEC / FDA Approval
Alphatec Spine, Inc changed management and their company brand to ATEC around 2017. The new management at ATEC recognized the value of Osseoscrew and under their direction resubmitted the screw for FDA approval. With their efforts, the FDA in 2018 gave initial approval for the use of OsseoScrew in patients with weak bones from conditions like cancer who may not survive until the spine fuses. Clearly the FDA recognized that the increased strength of these anchors would provide stabilization in patients with clearly dire problems in their spine. Consequently, the product has been made available for use in the United States market.
Wyoming Spine and Neurosurgery and Cheyenne Regional Medical Center
The first OsseoScrews were placed in the United States by Dr. Beer at Cheyene Regional Medical Center on November 29, 2018. The screws were placed seamlessly and resulted in excellent initial fixation for our patient. This we believe was the first use of an exciting innovative spinal product which will change the way we address spinal instability in patients with weak bones in the spine nationally in the future.
Estimates suggest that the number of people older than 65 will more than double to over 70 million or more by 2030. Alongside this increase in the age of our population, conditions like cancer, osteoporosis, osteoporotic spinal fractures, acquired spondylolisthesis, spinal stenosis and adult spinal deformity will concurrently become more prevalent. Innovative medical devices like OsseoScrew are consequently needed and clearly result in better treatment options for aging patients and spinal conditions related to aging in these patients.