This news story attempts to explain the treatment options available for people who have severely disabling pain caused by osteoarthritis of the ankle. The article is generously sprinkled with both hope and caveats about the newest generation of ankle replacement implants intended to improve life for people like patient Dan Sivia: “Specialists hope… although it’s too soon to be sure.” “If the newer implants pan out…” “There is little research to tell how long newer versions will last…” Despite this attempt at even-handedness, however, readers are left with a fuzzy understanding of the potential harms of ankle replacements, little hard data about their potential benefits, virtually no understanding of the quality of the evidence on this topic, and no mention of a key source’s potential conflicts of interest.
The story provides good reasons to be cautious. So, in the end, why wasn’t it?
The article says that the costs of a typical ankle replacement can “reach $50,000.” However, it doesn’t mention the cost of the most common alternative, fusion, or take into account the future cost of treatment after the device fails.
The story provides no quantitative estimate of benefit from ankle replacement or ankle fusion—-no information about what patients would consider "real" outcomes. One meta-analysis has reported that 38% of patients treated with ankle replacement had an excellent result, 30.5% had a good result, 5.5% had a fair result, and 24% had a poor result. Among people who had fusion, the corresponding numbers were 31%, 37%, 13%, and 13%. (J Bone Joint Surg Am. 2007;889(9):1899-905.) Even reporting the research on earlier generations of ankle replacement would be helpful, since it would reinforce the message that people should approach the new treatment with caution. It would be fairer if the writer simply stated that these are patients who have a real problem, but one that currently lacks a good, proven treatment option.
The article explains some of the potential harms and limitations of an ankle fusion, but says little about those of ankle replacement. What are the short- and long-term risks? (In the closing paragraph there is a vague reference to “different risks of wound infections” with different implants.) What does it mean when an ankle replacement “fails”? Is fusion usually still an option? This is not a simple procedure and complications are an important outcome.
For example, an analysis of more than 5000 patients in California found that people who received an ankle replacement had an increased risk of device-related infection and were more likely to require a major reoperation than people who had an ankle fusion. The rates of major reoperations after ankle replacement were 9% at one year and 23% at five years compared with 5% and 11% following ankle fusion. (J Bone Joint Surg Am. 2007;89(10):2143-9.)
The news story summarizes the literature on ankle replacement in a single sentence. The article says that a review in the Journal of the American Academy of Orthopaedic Surgeons (JAAOS) “cautions that so far, there is little research to tell how long newer versions will last—and that few hospitals have much practice in implanting them.” In doing so, the story cites one review article, no original research, and makes no attempt to characterize the quality of the clinical evidence to support the review’s conclusions.
Although it issues a number of caveats, the story fails to simply state that there are no large, long-term studies examining these devices. Part of the problem is the "FDA approval". To the lay person, this may imply efficacy even though it often requires only a minimum amount of short-term evidence.
The article says some 200,000 people seek care for their ankles annually. A reader could come away with the mistaken impression that there is an alarmingly high prevalence of ankle pain that is disabling enough to warrant an ankle replacement. The actual prevalence is unknown, but is likely to be a small proportion of that number, though more than the 10,000 or so annually who are currently getting fusions and ankle replacements.
The story fails on a critical point: It neglects to mention key potential conflicts of interest in its main expert source. The story includes interviews with one patient who had a successful ankle replacement and one surgeon (Dr. Haddad) who is currently developing an ankle replacement implant for Wright Medical Technology and is also the lead investigator in a trial sponsored by device maker DePuy Orthopaedics of a DePuy ankle implant, according to Haddad’s website. The story briefly cites a second orthopaedic surgeon (Dr. Wapner), who is said to believe that the newest implant designs will last longer than previous designs.
The story describes some of the pros and cons of ankle fusion, the main alternative to ankle replacement. It makes no mention of other surgical or nonsurgical treatments. According to the story, fusion appears to be a more predictable operation than ankle replacement, but also one that triggers unwelcome long-term problems.
The story explains that ankle replacements have gone out of favor and that device makers are attempting a comeback with a “third-generation” model. It also explains that the FDA began approving the current generation of implants in 2005, but few hospitals have experience with the procedure.
The story explains that ankle replacement has been around for decades, but that a new generation of implants was recently approved in 2005.
The story uses several sources and does not appear to rely solely or largely on a news release.