A discussion on the new technology overview from the AAOS
At its December 2010 meeting, the AAOS Board of Directors approved two technology overviews on the surgical and nonsurgical treatment of ankle arthritis. Afterward, Judith F. Baumhauer, MD, MPPH, president-elect of the American Orthopaedic Foot & Ankle Society (AOFAS), assembled a roundtable discussion on the report. Participants included Stephen J. Pinney, MD; Charles L. Saltzman, MD; Lew C. Schon, MD; and Michael J. Coughlin, MD.
Dr. Baumhauer: Let’s begin with a definition of an AAOS technology overview.
Dr. Schon: A technology overview is essentially a review of the literature—a systematic, evidence based process that scrutinizes all prospective and/or controlled studies to provide information for clinicians to understand the status of the technology. Clinicians can then use the information in discussions with patients. It is not intended to guide clinical care, direct policy, affect insurance coverage, or create standard of care in a legal sense.
Dr. Pinney: This technology overview was a product of the Academy’s ankle arthritis guidelines work group under the jurisdiction of the AAOS Guidelines and Technology Oversight Committee. The original goal was to develop evidence-based guidelines for ankle arthritis. Unfortunately, relatively few studies met the inclusion criteria. For this reason, the work group decided to produce a technology overview that simply summarized the results.
Dr. Baumhauer: We want those big, randomized, controlled trials to guide us, but how often do those studies occur in orthopaedics? Do you have any thoughts about evidence-based medicine guiding our treatment of patients?
Dr. Saltzman: Large, randomized, comparative effectiveness research trials don’t often occur in orthopaedics. Conducting such a study could be an ethical problem for most surgeons and patients who are considering surgical treatment. Level I evidence is a laudable goal but equipoise (having two or more equally appropriate options) in surgical decision-making almost never exists. Patients and doctors need to make decisions that fit their specific needs.
Implants and reported outcomes for total ankle arthroplasty (TAA) have consistently improved over the past 40 years, and I expect that trend to continue. The same is true of fusion, although the differences have been less dramatic.
Dr. Baumhauer: How common is ankle arthritis?
Dr. Pinney: An AOFAS member commonly sees this condition. But it’s substantially less common than other forms of arthritis. We do know that ankle arthritis has an impact on patients’ lives that is similar to that experienced by patients with end-stage knee and hip arthritis.
Dr. Saltzman: I have seen several estimates from different sources indicating that about 25,000 ankle arthrodeses are performed each year.
Dr. Baumhauer: Historically, ankle fusion has been considered the best treatment for end-stage ankle arthritis, although ankle replacement has had some resurgence in the last 10 years. What is the level of evidence for performing fusion? And, if fusion works, do we really need a TAA?
Dr. Coughlin: Little scientific information of value can be found on either TAA or ankle arthrodesis. Our 2009 study found no Level I publications on either procedure. To make conclusions based on publications from 30 or 40 years ago really serves little scientific purpose.
Dr. Pinney: We know from anecdotal and lower-level studies that, when performed appropriately in the right patient, ankle fusion can work well as a treatment for ankle arthritis. But ankle fusion is not perfect. The ability to preserve ankle motion and to provide dramatic pain relief are laudable goals and TAA offers that potential.
Dr. Baumhauer: Based on what we know from other orthopaedic specialties, such as the hip and knee, and with the resurgence in TAA, do you expect to see a shift from fusion to joint replacement in the ankle?
Dr. Schon: Absolutely. I anticipate we will look back on ankle fusion the way we view knee and hip fusions. Arthroplasty in those joints is far superior to fusion. Our goal in orthopaedics is to decrease pain and improve function.
The first generation of implants designed for the ankle was not so good, but offered some important lessons. The second and third generations are much better, with improved techniques, surgery, and selection. Based on current advances, the technology and technique will continue to evolve.
When we perform an ankle fusion, the patient no longer has motion in that joint. Consequently, the stresses during activities are transmitted to adjacent joints, leading to adjacent joint arthritis. Some patients may have difficulty functioning in certain circumstances such as rising from a chair, squatting, or kneeling. Some patients will accept those limitations, but others will not.
Better technologies and techniques will give people the chance to keep functioning longer. Ankle fusion is a good solution but ankle replacement, in the future, will be even better.
Dr. Baumhauer: What are the indications and contraindications for TAA?
Dr. Saltzman: As the reliability of ankle replacement has increased, the criteria have changed. In general, the young patient who wants to be active, who is obese, who is going to expose the ankle to repeated high-impact loads today should be treated with a fusion. The older patient who has a well-aligned ankle, good bone stock, with lower demands may reasonably consider an ankle replacement. Other criteria might be based on the patient’s comorbidities, outlook on life, interest in life, and adjacent joint arthritis.
Dr. Pinney: Some patients seem to benefit much more from an ankle replacement than an ankle fusion, including older patients with lower demands and patients with significant involvement of the surrounding joints. Those patients will typically do well with TAA.
Dr. Baumhauer: We have to use our good clinical judgment in making these decisions. Can you summarize your recent prospective study on TAA versus arthrodesis, Dr. Saltzman?
Dr. Saltzman: We conducted a prospective, controlled trial of a second-generation total ankle replacement versus ankle fusion. At 24 months, ankles treated with TAA had better function and equivalent pain release as ankles treated with fusion. Complications were also equivalent. So this study suggested that in this population, with this implant, replacement was equal to or better than fusion at 24 months.
Dr. Baumhauer: What outcome measures were used?
Dr. Saltzman: The outcome measures for failure were very clear—device failure, revision, or removal. But the efficacy outcome measure was a 40-point improvement in the Buechel-Pappas ankle score.
Dr. Baumhauer: What are your thoughts about the possibility of unintended consequences from this technology overview? For example, do you think there could be insurance coverage decisions or standard of care issues?
Dr. Schon: I’m worried about the unintended consequences that could occur if this information is taken out of context. Insurance companies might ask why they should cover the procedure without extensive Level I studies. Questions about level of evidence might be asked by the government, with regard to Medicare or Medicaid coverage of this technology. Could a lawyer accuse a physician of doing the wrong thing, based on the fact that inadequate evidence exists to support the medical decision?
We need to perform multicenter, prospective, controlled studies and look at new devices with a higher level of scrutiny. Level 3 and 4 studies can provide baseline information to advance the field and the research. Let’s not put a damper on enthusiasm or choice.
Dr. Coughlin: Currently, insurance coverage is a terrible problem. Insurance companies may refuse payment for TAA based on their notion that it is experimental. One of my patients was refused a second procedure; the company claimed that although studies showed satisfactory results with unilateral total ankle replacement, no studies demonstrated that bilateral TAA was beneficial.
Dr. Pinney: The technology overview is really a presentation of the current literature. If we could have drawn any conclusions, we would have put them in the form of a guideline. Both ankle arthro-desis and ankle replacement were deemed to have inadequate literature to make a conclusion. The inclusion criteria were such that a number of studies that seemed to provide meaningful information had to be excluded.
Dr. Baumhauer: What are your thoughts about the challenges that we face, particularly in foot and ankle, in doing research? Do other specialties have the same problems?
Dr. Pinney: One of the issues was that we decided to exclude any study that wasn’t based on prospectively collected data or did not have a control group. That eliminated many retrospective reviews. In terms of research on the foot and ankle, it’s difficult to have large numbers of patients in studies from a single center. Foot and ankle surgeons see such a wide variety of conditions, achieving appropriate numbers for a study may be almost a career’s worth of patients.
One solution would be to do multicenter studies, but these also have inherent challenges, such as the numbers issue, plus the fact that many conditions can be treated in different ways very effectively. That became apparent as we looked at the studies on ankle arthritis.
Dr. Coughlin: No question, the gauntlet has been thrown down. We must implement prospective studies on arthrodesis and TAA to demonstrate the differences, improvements, and benefits of TAA. Unfortunately, this takes time and money and doesn’t help the patient who has arthritis of the ankle now.
The most recent new implant costs in the range of $25 million to $30 million to develop. The ankle is an orphan joint, and large implant companies have little interest in developing new designs. The loss of insurance coverage for TAA would severely impair progress in developing new designs in America.
Dr. Baumhauer: Let’s summarize this discussion. How can we address these challenges?
Dr. Schon: The best outcome of this technology review is that we have learned a lot. We are already designing better multicenter, prospective studies. Further analysis must capture what we hear from our satisfied patients. We will need to be more specific in our outcome measures and use existing assessment tools better. We also need to develop clinical registries and collect pertinent long-term data on this topic. The AOFAS is examining options for database management to facilitate outcomes research for foot and ankle procedures. I am certain, based on the study design improvements, that we will be able to provide satisfactory level of scientific evidence.
Dr. Saltzman: Although a review of the literature and examination of the evidence supporting treatment options in orthopaedics is important, the rate at which new evidence is increasing is nothing less than exponential. To advance the field and, more importantly, to improve care and function for our patients, we need careful and continued review of the evidence and thoughtful analysis.
Judith F. Baumhauer, MD, MPPH, is president-elect of the AOFAS. Stephen J. Pinney, MD, served on the task force that developed the technology overviews on surgical and nonsurgical treatment of ankle arthritis. Charles L. Saltzman, MD, is the immediate past president of the AOFAS. Lew C. Schon, MD, is the vice president of the AOFAS. Michael J. Coughlin, MD, is a past president of the International Federation of Foot & Ankle Societies.