The following article was sponsored by Stryker. Augment® is a Stryker product.
The views, opinions and product experiences discussed in this article, whether implicit or explicit, are those of Dr. McCormick and do not necessarily reflect the views and opinions of Stryker. Proper surgical procedures and techniques are the responsibility of the medical professional, and a surgeon must evaluate the appropriateness of the procedures based on his or her personal medical training and experience. Prior to use of any product the surgeon should refer to the package insert for complete warnings, precautions, indications. contraindications and adverse effects.
Dr. Jeremy McCormick is a paid consultant of Stryker.
Performing surgery with predictable results is every surgeon’s goal. Indeed, part of a surgeon’s responsibility is to try and predict likely and unlikely treatment outcomes by using their expertise and the resources at their disposal to achieve the best possible results for their patients. This, of course, while trying to mitigate the risks of possible complications. For surgeons like me who have been practicing for nearly 15 years, this comes as no surprise. In our profession, in a general sense, we can be hesitant to adopt new technologies because of lack of familiarity with newer techniques as well as the potential lack of access to new products. In many cases, new technologies exist with the aim of optimizing results. One example of this is Augment® Regenerative Solutions.
One of the most common surgeries in my specialty of orthopaedic foot and ankle surgery is arthrodesis – or fusion surgery. Fusion is a core procedure of foot and ankle surgery as a means to reduce pain and, in turn, increase function for patients afflicted with degenerative conditions of joints of the foot and ankle. Every year, the next generation of foot and ankle surgical trainees will learn and hope to master the surgical approach of fusion that thousands of patients will undergo annually. While new approaches to treating patients suffering from debilitating pain are becoming more and more common, fusion remains a standard approach for degenerative joints of the foot and ankle for experienced and newer surgeons alike. The question then is, why has a concerning risk of fusion surgery still not been addressed in patients receiving arthrodesis?
A significant risk associated with arthrodesis is non-union, or lack of bone fusion. For some patients, the risk of non-union can be high. Patient anatomies vary, as do their physiological and medical histories. Depending on the site of fusion or the host, non-union rates can be up to 40 percent in some high-risk sub-groups, a high rate and a high risk for both patients and surgeons alike.[i] While careful surgical technique can theoretically reduce the risk of non-union, surgeons still rely on the patient’s biology to heal the attempted bone fusion.
Healing is a complex physiological process. In arthrodesis, it involves the recruitment of cells to the site of fusion (chemotaxis), the creation of new blood vessels (angiogenesis), and the induction of replication of those cells at the site of fusion (mitogenesis). For surgeons performing arthrodesis, facilitating and ensuring that these complex processes occur is challenging, specifically in patients whose comorbidities may leave them vulnerable. As such, these higher risk patients may be less likely to experience timely healing and adequate bone fusion.
Many patients in need of arthrodesis surgery are older (60+) and therefore less likely to heal entirely on their own and at a suitable pace.[ii] Additionally, patients with risk factors such as a history of smoking and diabetes can also face difficulty accomplishing the biological processes necessary to achieve fusion. Because achieving fusion is necessary to help patients who are frequently in significant pain, it is important to optimize conditions for bone fusion by considering every tool at a surgeon’s disposal to address the challenges of healing.
An example of a biologic adjunct that can be considered at the time of fusion surgery is Augment. Augment Injectable and Augment Bone Graft are the first and only FDA-approved alternatives to autograft for ankle and hindfoot arthrodesis. Augment facilitates multiple facets of the healing process through delivery of a recombinant human platelet-derived growth factor (rhPDGF-BB) to the site of fusion, along with an osteoconductive tricalcium phosphate carrier. This unique Biologic solution also ensures a consistent delivery and concentration of the powerful growth factor, thereby addressing the potential irregularities of the healing process in patients with diverse and potentially challenging host factors. What makes Augment a valuable tool in the treatment landscape is its impact on those most susceptible to non-union. While arthrodesis may be considered a relatively routine surgery for younger, healthier patients whose bodies are well-suited for proper healing, achieving fusion can be challenging in the aforementioned at-risk patient populations.
As I previously mentioned, two of the most common barriers to utilizing new technologies like Augment are surgeon willingness to adopt a new technique and cost. Surgeons are committed to providing the best care to all patients. The benefits of using technology such as this are more reproducible and reliable outcomes, particularly in high-risk patients. In terms of cost, mitigating the risk of revision surgeries can lower overall costs for healthcare facilities, but it should also be noted that Augment has received special approval by the Centers for Medicare & Medicaid Services (CMS) for pass-through payment eligibility. This allows facilities to be fully reimbursed for using Augment for on-label indications, and in the outpatient care setting. Unfortunately, barring an extension, this special approval will expire at the end of 2022.
Products like Augment have the potential to improve the healing process and outcomes of those patients undergoing arthrodesis surgery. It may lead us to further refinement of arthrodesis surgery by increasing predictable outcomes. Surgeons should feel confident using Augment because of the existing efficacy data highlighting the increased fusion rates in older patients, the mechanism by which the PDGF affects multiple points on the bone healing cascade, and the fact that Augment has been reviewed and approved by the FDA as a safe and effective solution for hind foot and ankle fusion.
It is my hope that this piece will encourage surgeons to consider utilizing Augment and advocate for wider accessibility. With the primary goal of arthrodesis surgery being pain relief, accomplished most reliably through predictable healing of the fusion surgery, surgeons should consider offering all possible solutions that can help patients heal and help us advance healthcare as a whole.
Dr. Jeremy McCormick serves as Associate Professor and Chief of Foot and Ankle Surgery in the Department of Orthopaedic Surgery at Washington University in St. Louis.
[i] Lawton, C.D., Butler, B.A., Dekker, R.G. et al. Total ankle arthroplasty versus ankle arthrodesis—a comparison of outcomes over the last decade. J Orthop Surg Res 12, 76 (2017). https://doi.org/10.1186/s13018-017-0576-1
[ii] Berlet, Gregory C. MD, FRCSC1; Baumhauer, Judith F. MD, MPH2; Glazebrook, Mark MSc, PhD, MD, FRCSC3; Haddad, Steven L. MD4; Younger, Alastair MD, FRCSC5; Quiton, Jovelyn D. MSc6; Fitch, David A. PhD6; Daniels, Timothy R. MD, FRCSC7; DiGiovanni, Christopher W. MD8 The Impact of Patient Age on Foot and Ankle Arthrodesis Supplemented with Autograft or an Autograft Alternative (rhPDGF-BB/β-TCP), JBJS Open Access: October-December 2020 - Volume 5 - Issue 4 - p e20.00056 doi: 10.2106/JBJS.OA.20.00056 https://journals.lww.com/jbjsoa/fulltext/2020/12000/the_impact_of_patient_age_on_foot_and_ankle.9.aspx