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Innovation is important, but also imparts new level of risk, potential complications
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The New York Times recently published a story about a lawsuit brought against the OtisMed Corporation for distributing the OtisKnee without the appropriate FDA approval. The story, as told through one patient’s experience with a failed primary total knee replacement, calls into question not only the process by which new orthopedic technology is brought to market, but equally important, the choices orthopedic surgeons make on a daily basis when deciding on implants and devices to use for patients.
Unfortunately, the example of the OtisKnee is not unique. Orthopedic journals routinely report on recently introduced implants, which have been hailed as a solution to past problems, but fail to outperform previous designs. While it is impossible to study every new technology with evidence-based level 1 or 2 studies, it is frustrating that we need to make critical decisions based on weaker level 4 studies or the often-biased level 5 studies.
More problematic is when new designs perform poorer, or in the extreme case, cause patient harm. This is generally when the reports cease to be isolated to the orthopedic community and become larger public stories. The best recent example is metal-on-metal (MoM) total hip arthroplasty failures. When MoM devices were introduced, published reports indicated the implants had the potential to solve the issue of bone loss and late loosening of joint implants by removing the primary cause of osteolysis — polyethylene — from the joint-bearing surface. However, after mid-term follow-up, medical delivery systems and orthopedic societies outside the United States reported an alarming rate of complications and previously rare conditions, such as soft tissue pseudotumors, caused by the byproducts of the MoM implants. After other countries recalled some systems due to complication rates higher than previously available technology, U.S.-based companies and surgeons responded, but not before many patients had the devices implanted.
Anthony A. Romeo
The story of the OtisKnee is different. The cutting jigs the company manufactured for total knee arthroplasty were not implants patients carried in their bodies, but were tools used to theoretically improve outcomes of already tested, stable implants. This broadens the level of scrutiny to not only include implants, but also instruments, guides and surgical techniques used during the surgery.
Delicate balance
People not involved in areas of medicine who routinely use implants and devices see these transgressions as a huge breach of trust and a form of misconduct. However, those who routinely use devices and implants know how delicate a balance this can be. There is the desire to always do better. We are taught to be critical of our work and find ways to do it more efficiently, safely and consistently. In orthopedics, this means using new and different devices and implants. However, we are also patient advocates. We are charged with correctly diagnosing and treating patients in ways that not only help them, but also minimize the chance of harm.
Further complicating the situation is the close relationship that may exist between an orthopedic surgeon and industry. This relationship exists as a spectrum, where some surgeons work closely with industry, developing and designing new tools and implants, and others surgeons have no relationship other than that of their local industry representative, who is present when one of their products is being used. While to outsiders this relationship can appear to be an insurmountable conflict of interest, those in the orthopedic profession know how important such relationships can be to promote innovation and improve patient care.
Another area where this relationship has become more difficult is in the overall cost of providing orthopedic care. Many devices we use today have not changed substantially when we look at the principles of using the device. Most common arthroscopic procedures include the implantation of a screw or anchor. The principles behind the effectiveness of the devices has undergone minimal change during the past 10 years. However, as we will see at this year’s American Academy of Orthopaedic Surgeons Annual Meeting, our senses are overloaded with new implants, proposed improvements and well-respected surgeons who educate on how the new devices can solve current problems.
Promoting and incorporating innovation in practice without strong unbiased scientific support can conflict with the efforts to do what is right for patients, both in terms of effectiveness and safety. New devices and implants should undergo rigorous testing before they can be implanted or used in a patient. In addition, once implants or devices are released for use in patients, outcomes should be followed to ensure no unanticipated adverse events and the device performs at least equal to currently available options. It can take years for a well-designed study to confirm if the clinical results are better than what is already available.
Decision-making process
The end-result idea by Ernest Amory Codman, MD, is almost 100 years; old, however, the creation of society-based registries in the United States is a relatively recent phenomenon. The governments of countries outside the United States have required the participation in registries for many years. More recently, other third parties have initiated the development of registries outside the boundaries of government or orthopedic societies.
As surgeons acting as advocates for patients, we have a personal desire to participate in this process. However, registries are time-consuming and expensive, and the cost would be prohibitive if it was entirely based on practicing surgeons to organize, develop software and manage data. We need to work with these organizations to create a process that improves the ability to make good decisions for patients.
M. Michael Khair
We all go through a sophisticated decision-making process every day when we decide whether to offer nonoperative or surgical care as well as which instruments, devices and implants to use. We try our best to weigh the evidence — if any exists — to not be swayed by the promise of what is new, exciting and full of potential over that which we know through time and trial works effectively and safely. While it can be tempting to be on the cutting edge and try new technology, surgeons and patients would be better served by changing the mindset to ask, “What is the most stable technology” or “What do I know will most effectively and safely treat this patient’s pathology?”
Patient care
While the term “informed consent” has been around for more than 50 years, its definition and application by individual orthopedic surgeons continues to be the subject of debate. Most surgeons explain the risks and benefits of a procedure in generic terms and will cite percentages based on their understanding of the literature. Surgeons have not always been as clear when discussing the implants or technology planned for use. This may become a routine aspect of consent whenever a device is used, especially one that has been recently introduced into the market or the surgeon’s practice. The reality is this description can be technical and difficult depending on the nature of the device or implant and is not necessarily an easy thing to describe or convey to patients. Nonetheless, it generally is an area that needs improvement in terms of patient communication.
Innovation is important to advance patient care. We have witnessed some truly transformational innovations. We want patients to respect our ability to make decisions about what is in their best interests. This respect, however, must have foundation in a trust that the surgeon is going to make unbiased decisions based on a patient’s specific problem. This trust can be strengthened when the surgeon involves the patient in the decision-making process.
Before we decide to try a new instrument or device, we need to always ask if we have a stable, cost-effective alternative with a proven track record. If so, then we should be careful when choosing to forgo that option. We also need to make sure patients are aware of the choices we make and the reasons for these choices. While innovation is important, it also imparts a new level of risk and potential complications. We should do what we can to minimize those risks for the people for which we have the responsibility and privilege to provide care.
Reference:
Allen M, et al. Knee replacement device unapproved, but used in surgery. The New York Times; Feb. 6, 2015; http://www.nytimes.com/2015/02/08/business/knee-replacement-device-unapproved-but-used-in-surgery.html?partner=socialflow&smid=tw-nytimes
For more information:
Anthony A. Romeo, MD, is the Chief Medical Editor of Orthopedics Today. He can be reached at Orthopedics Today, 6900 Grove Rd., Thorofare, NJ 08086; email: orthopedics@healio.com.
M. Michael Khair, MD, is a sports medicine fellow at Rush University in Chicago. In addition to doing post-graduate work at the Hastings Center in Garrison, N.Y., he was a member of the Bioethics Committee at Hospital for Special Surgery while he completed his orthopedics surgery residency.
Disclosures: Romeo receives royalties, is on the speakers bureau and a consultant for Arthrex Inc.; does contracted research for Arthrex Inc. and DJO Surgical; receives institutional grants from AANA and MLB; and receives institutional research support from Arthrex Inc., Ossur, Smith & Nephew, ConMed Linvatec, Athletico and Miomed. Khair reports no relevant financial disclosures.