Robert M. Orfaly, MD, MBA, FAAOS

AAOS Now

Published 12/20/2023
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Robert M. Orfaly, MD, MBA, FAAOS

How Should Orthopaedic Surgeons Responsibly Introduce Innovation?

It has been 20 years since the FDA released the first reverse total shoulder arthroplasty implants for use in the United States. I recall telling patients at the time to wait a few extra months for surgery because I would have this far superior option available for them soon. Looking at how the world of shoulder arthroplasty has evolved since then, this technological innovation has truly revolutionized any shoulder arthroplasty practice and the results we achieve for our patients. However, this innovation was not without challenges and failures. From the earliest days of shoulder replacement, surgeons have developed anatomical and nonanatomical designs with enhanced constraint. Paul Grammont, MD, introduced his reverse shoulder arthroplasty in 1985, and it was first used in France in 1991. It was a very slow process of more than a decade before it could first be used in the United States, and many refinements have been offered since then.

Around the same time, thermal capsulorrhaphy, or shoulder capsular shrinkage, was also developed as an alternative form of arthroscopic treatment for shoulder instability. In the decade following its introduction in 1996, it rapidly gained popularity among many orthopaedic surgeons. It is my impression that the innovation benefitted from the shorter procedure time and simpler technique required compared with conventional capsulolabral reconstruction. It also used thermal systems that could often be purchased as add-ons to existing arthroscopic equipment. I had patients specifically requesting the procedure as they had read online reports expounding the benefits of this method of stabilization. Unfortunately, studies demonstrating good early results were followed by concern regarding significant complication rates and later-term failures. As it turns out, heat does make capsular tissue shrink, but it also leads to many other changes to tissue structure and mechanical properties that are not advantageous. Misplaced or excessive heat can also cause serious injury to cartilage and nearby nerves. Nowadays, it is rare that any of my residents have even heard of thermal capsulorrhaphy, as it has been abandoned.

Investigating innovation
The theme of this month’s edition of AAOS Now focuses on innovation. I therefore think it is appropriate to offer some potential controversy and invite a conversation about how and when innovation gets introduced into our practices. What are the differences between the case studies of reverse shoulder arthroplasty and thermal capsulorrhaphy, and how do we preemptively make the distinction when deciding on new techniques and technology to adopt in the care of our patients? Who is in the best position to make these decisions and at what point during the development and adoption? What data should be available to make these decisions? I am certainly no expert in these matters but will offer a personal opinion with which you may agree or disagree.

I have always espoused the concept of “if it ain’t broke, why fix it?” If two procedures have similar outcomes and costs, the one with longer and more robust follow-up will usually be my choice. The mere fact that more is known seems to be a very important point of superiority. Even when only considering quality of outcomes, the older technology tends by its nature to also be lower cost. Pursuing this strategy can be difficult in this internet age when patients frequently present requesting the latest technology being advocated. However, here too we have a collective obligation in how we discuss and write about potential innovations. We need to work with each other, our health systems, and our industry partners to ensure that there is adequate separation of objective scientific results from the marketing of new technology that lacks clear superiority.

One important factor in my speed of adopting new procedures is the adequacy of current treatments. In the case of cuff tear arthropathy and many revision arthroplasty scenarios, the treatment results prior to reverse shoulder replacements were distinctly in the “salvage procedure” category of guarded expectations. I now see some patients presenting with massive bone and soft-tissue deficits who achieve a level of postoperative pain relief and function that can rival a straightforward primary osteoarthritis patient. In contrast, open and arthroscopic labral reconstruction for shoulder instability was producing reliable results for the patient populations considered for capsular shrinkage. Although I agreed with the need to investigate this emerging technology, I personally questioned the degree to which it supplanted more established procedures for a period of time when superior results were not well established and little was known about the long-term consequences. Thermal capsulorrhaphy is far from the only innovation that has followed this unfortunate path. As just one additional example, does anyone recall another innovation from the 1990s referred to as Hylamer polyethylene?

Evaluating trends
I believe unequivocally that orthopaedic surgeons are the most qualified professionals to engage in shared decision making regarding the optimal treatment for our individual patients. We are also necessary partners with entities such as the FDA, which regulate the use of certain technology. Although I know less than many regarding the execution of clinical trials and database management, my experience in advocacy makes me acutely aware that surgeons, patients, and even government regulators are becoming secondary players in the decisions regarding which innovations become standard of care.

Increasingly, insurance coverage decisions are the most important factors influencing the type and timing of care delivered. I do not see this trend as being in the best interest of our patients. It should serve as a rallying cry to arm ourselves with the best evidence and practice standards to fight this trend and preserve this aspect of practice autonomy.

AAOS is a natural convener of allies and resources for this task. Many of the brightest scholars of our profession will be meeting in February 2024 to discuss innovations at our Annual Meeting. Our scientific journals provide data to support changes in patient care, and up-to-date summaries of best practices can be found in our Clinical Practice Guidelines, Appropriate Use Criteria, and Biologics Dashboard. Appropriate expectations can be set by directing patients to accurate, peer-reviewed information at OrthoInfo.org.

We are strongest when working in the collective, but I also see a personal imperative for each of us to avoid perpetuating the concept of a “medical arms race” that is not based on objective evidence of improved value for the patient. By our nature, orthopaedic surgeons love our tools and technology and the way we can use them to restore mobility and function. It is not always possible to accurately predict which innovations will be truly revolutionary, but I think there are times when restraint is in order if good results are achieved with a new version of a technique that already produces good results.

It is encouraging to see that, along with technical advancements, greater discussion and study are being directed toward factors that affect the variability of those results, such as medical comorbidities and social determinants of health. Whether developing individualized risk calculators to use in shared decision making or advocating for upstream improvements in overall wellness of the populations we serve, these innovations deserve equal consideration and attention as we have given the more familiar technological ones. In general, I try to adhere to the following adage when evaluating clinical implementation of new technology: “Don’t be the first one to pick up the sword, but don’t be the last one to put down the shield.”

I hope you enjoy reading about many of the inspiring innovations featured this month and yearlong in AAOS Now. I also encourage all to read critically and judge for yourselves which novel ideas are most likely to be the gamechangers that truly advance our profession.

Robert M. Orfaly, MD, MBA, FAAOS, is a professor in the Department of Orthopaedics and Rehabilitation at Oregon Health and Science University. He is also the editor-in-chief of AAOS Now and chair of the AAOS Now Editorial Board.