Frederick A. Matsen III, MD, is a Professor of Orthopaedics and Sports Medicine at the University of Washington. His life in shoulder orthopedics began with a fellowship in 1975 with Charles Neer at Columbia Presbyterian Hospital in New York City, and he was a founding member and past president of the American Shoulder and Elbow Surgeons. Dr. Matsen’s clinical, research, and teaching interests focus on primary and revision shoulder arthroplasty.
In the preface of our 1994 book, Practical Evaluation and Management of the Shoulder , we stated, “This book is directed at the type of practice we see evolving for the coming decades, when resources will not be as plentiful and increasing premiums will be placed on economy and effectiveness.”
The intervening quarter of a century has witnessed a virtual explosion of new technologies in shoulder surgery. Although exciting, attractive, and potentially beneficial to our patients, each new technology carries with it new costs of research, development, US Food and Drug Administration (FDA) clearance, marketing, surgeon education, and learning curves, as well as the risk of unanticipated difficulties and complications, which may not become evident until years after the introduction of a new product.
A telling example is the introduction in the early 2000s of “pain pumps” to infuse local anesthetics into the joint as a means for controlling pain after arthroscopic shoulder surgery. Fully a decade later, it was noted that young patients were at risk for severe arthritis after shoulder arthroscopy when pain pumps were used, especially in young patients having suture anchor repairs. This condition, known as chondrolysis, results in the devastating loss of articular cartilage in a previously nonarthritic young shoulder ( Figs. 70.1–70.3 ). In spite of compelling evidence of the relationship of pain pumps to chondrolysis, , articles published in our major journals stated that the “etiology [of chondrolysis] remains unclear, but the disease process is likely multifactorial” and that “despite speculation among clinicians and researchers about the implicit causal pathways and etiologic contributors associated with chondrolysis, definitive answers remain elusive.” It was not until 13 years after the initial articles advocating the use of pain pumps that the central role of these devices in causing chondrolysis was definitively proven and their use curtailed. Sadly, we are still seeing young patients suffering the consequences of this condition.
A major issue for us shoulder and elbow surgeons is that many new technologies are being introduced to the marketplace each year ( Fig. 70.4 ) without evidence that they are safer or more effective than the technologies in current use. Problems with new devices may not become evident until years after their introduction to the market and after these devices have been implanted in many patients. , Most orthopedic devices are not “approved” by the premarket approval process that the FDA uses to test the safety and efficacy of new drugs, but rather they are “cleared” by the 510(k) process, which requires the manufacturer only to demonstrate that the new device is similar to another device that has been previously marketed, even if the prior device has been withdrawn from the marketplace. Almost 20% of the devices cleared by the 510(k) process end up being recalled; 510(k)-cleared devices are 11.5 times more likely to be recalled than premarket approval–approved devices. As in the case of the pain pump, problems with new devices are often not identified and managed until years after the device’s clinical introduction and until thousands have been implanted. A recent example is that of a certain reverse total shoulder cleared by the 510(k) process in 2008, 3662 of which were recalled over 8 years later because of a fatigue fracture problem with the titanium stem of the humeral tray ( Figs. 70.5 and 70.6 ). Although we have become accustomed to the frequent recall of automobiles because of faulty steering mechanisms and airbags, recall of a device implanted in one of our patients is a different situation altogether. The issues with the way in which the FDA allows new devices to come to market are highlighted in a recent book by Jeanne Lenzer, The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It . Although new technologies, such as stemless or short-stemmed humeral components, three-dimensional computed tomography (CT)-based preoperative planning, and patient-specific instrumentation, may seem attractive, we must ask whether they provide increased net benefit to the individual patient we are treating in comparison with standard and less-expensive techniques that have been in place for decades.
One way to think about newer technologies is to ask what is the appropriate “tipping point” for their use; that is, what combination of circumstances would cause us to jump from the “tried and true” to the “new.” , Here are five such questions for us to consider:
- 1.
The CT scan is being extensively advocated for the routine preoperative assessment of an arthritic shoulder, while for decades shoulder arthroplasty was successfully carried out without this added expense ($500 to $1000) and added radiation (50 to 100 times) in comparison with plain films. A standard axillary “truth” view taken with the arm elevated in the plane of the scapula ( Fig. 70.7 ) provides all the information needed to plan surgery in all but the most unusual shoulder pathoanatomies. In our practice we rarely get to the tipping point of ordering a preoperative CT; rather we find that the “truth” view reveals sufficient anatomic detail to guide our discussions with the patient and our surgical planning ( Fig. 70.8 ). The axillary “truth” view has the additional advantage of facilitating the side-by-side comparison of the preoperative and postoperative shoulder anatomy, so we can see how well we did in addressing the pathology ( Fig. 70.9 ). What should tip us over to obtaining a preoperative CT scan?
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