Patrick Weidle, chief physician of the musculoskeletal centre in Neuwek Hospital, Germany, says now is the time for a new generation of products, featuring a modular technology that is respectful of patients’ unique spinal conditions.
Spinal fusion surgery is one of the most common options for back-related pain and, over the years, it has given crucial relief for many patients requiring spine treatment. However, its results have been debated since outcomes sometimes do not meet surgeons and patients’ expectations. In fact, it can result in what is known as the failed back surgery syndrome; a multifactorial issue with many aspects, among them: adjacent segment disease, post-operative pain, implant failures or loosening, some of which have the potential to trigger secondary surgery, whose efficacy is further debated.
Historically, while pedicle screws and associated instruments were initially designed for the treatment of spinal deformities, their use has gradually been expanded to degenerative indications over the past 25 years. However, to this day, the medtech industry has proposed only incremental innovations. Using the same products, technology and techniques for different indications and aetiologies has meant in some instance placing instruments too forcefully on patients’ spines, which can be described as forced fixation. A direct consequence can be a stress overload on patients’ spines with a domino effect generating a 3D spinal imbalance, as non-physiological forces and unwanted strain gradually change the natural biomechanics of the spine. This breakdown of the anatomical and biomechanical balance of the patient’s spine may trigger a chain reaction resulting in a revision surgery.
In the end, performing spinal fusion surgery with instrumentation that disregards each patient’s unique spinal condition bears the risk of not addressing the patient’s initial disease state, but also potentially worsening their short and long-term situation. This situation raises the question of what is a fusion at all cost worth. As some tools currently marketed by large medtech companies are not designed to offer the appropriate biomechanical and anatomical control of the forces exercised on patients’ spines, avoiding forced fixation is rarely possible for surgeons. And since those tools are widely distributed, despite their potential risks for patients, spinal fusion surgery is currently at a crossroad.
Faced with the finding that the stress factors created by current fixation devices can be much greater for the anatomy than anticipated, in some instances today’s industry has unfortunately embarked on an unsustainable quest for structurally more aggressive instrumentation, rather than a quest for more functional and physiological respectful options. It is therefore time for a new generation of products featuring a modular technology that is respectful of patients’ unique spinal conditions and can allow for controlled fixation and the achievement of a functional fusion, ensuring anatomically neutral, balanced, and stable spine load bearing. This is a first condition to offer more viable options that adjust to patients’ individual situations, so their quality of life may improve further.
But this is just a starting point. Sustainability in spinal surgery means going beyond, and implies providing greater value by limiting infections, reducing re-operation rates, de-cluttering the OR, to eventually reduce perioperative costs and risks. In fact, in 2011, spinal fusion surgery was the procedure with the highest aggregate hospital costs (12,837 million US$; 7.1 per cent) with mean costs of 27,600 US$ per hospital stay in the United States. Preparing the complex set of instruments and various screw options from different dimensions offered by manufacturers to accomplish this task prior to and after surgery involves numerous processes that have to be evaluated in terms of time expenditure, logistics, patient safety and total costs.
A recent study [1] published in Interdisciplinary Neurosurgery showed that such a value-based care approach to spinal surgery might start by reconsidering the impact of spinal surgery products sterilisation. According to the publication, time and cost savings can be obtained by using a unique universal and modular sterile platform in comparison to conventional reusable and re-sterilisable products thanks to, amongst other factors, improved instrumentation, surgical steps and the sterile packaging of instrumentation and screw kits. In fact, the study highlighted that the reprocessing costs and the re-sterilisation of legacy devices are the main drivers for additional indirect expenses due to surgery delays, cancellations and infection treatments.
From an environmental point of view, another recent study [2] reported a 75 per cent overall benefit for the application of a sterile single-use set with savings ranging from 45 per cent to 85 per cent on energy use, resource consumption, emissions of greenhouse gases and climate change. According to the study results, the main environmental impact for the reusable set is caused during sterilisation with the greatest effect due to energy consumption for washing and steam sterilisation.
We conclude that as health expenditure continue to rise steadily, new value-based care technologies focusing on improving clinical outcomes while reducing overall costs to the healthcare system are critical to make sure that patients continue to get the best care moving forward. New fit-for-value-based-healthcare solutions are needed to bring sustainability to spinal surgery by helping improve patient outcomes while optimising processes to reduce cost. Everybody, from patients, payers, to healthcare suppliers, stands to win when using our platform.
Recent studies [1, 2] show that sterile platforms with single-use modular instruments and universal implants significantly reduce the risk of contamination, corrosion, deterioration and damage. They can avoid costs and resources in hospitals for handling, storage and reprocessing. They reduce the rate of OR cancellation and delay, and help to decrease surgical site infection and thereby reduce the need of further healthcare. Such approach focusing on value-based care in spinal surgery is the only sustainable option today.
References
Abdalla Y. Value Based Healthcare: Maximizing efficacy and managing risk with spinal implant technology. Interdiscip Neurosurg 22 (2020) 100810. https://doi.org/10.1016/j.inat.2020.100810
Leiden A, Cerdas F, Noriega D, Beyerlein J, Herrmann C. Life cycle assessment of a disposable and reusable surgery instrument set for spinal fusion surgeries. Resources, Conservation & Recycling 156 (2020) 104704. https://doi.org/10.1016/j.resconrec.2020.104704