southern Sweden, he sensed the need for standardization and outcomes
assessment. What started as a multicentered endoprosthetic study among
small Swedish hospitals turned into the world’s first national joint
registry.^19
Because the regular ASR was resurfacing only, the FDA considered it a
new technique, and instead of considering it as a 510k device, it forced
DePuy to perform a clinical study that involves much greater scrutiny
(“investigational device exemption,” or “IDE”), thus greatly slowing the
rollout of the ASR in America. While the ASR patients in the IDE study
were being carefully followed by DePuy, the ASR XL recipients were not.
It will be surprising to readers that there is no formal mechanism for
implant manufacturers to track the success of their products in America. It
is more likely for Toyota to know about faulty exhaust pipes in a Prius
than DePuy to understand how a new hip implant is performing in the
United States.
In a joint registry, at first glance, it would appear that surgeons are
analyzing patients, but instead, it is the survival of the implants that is
studied. This is different than disease-based registries (like diabetes or
heart disease) that follow the vital status of the patients. At the time of
surgery, the patient is anonymously entered into a database, along with
information about the device, the surgical technique used, and the name of
the doctor. A national joint registry, therefore, provides valuable
information about the longevity of an implant when used in real-world
conditions by all surgeons. Because of this, there is no “cherry-picking” of
cases that are excluded from a surgeon’s publication on an implant he may
have designed. Surgeons are notoriously unreliable at self-reporting poor
outcomes; performance-oriented professionals are reticent to admit failure
(even when an innocent participant) or reveal an error in judgment.
National joint registries, therefore, are a critical tool for analyzing the
short, medium, and long-term outcomes of a joint replacement.
As of this writing, there are only eleven national joint registries in the
world: Sweden, Finland, Norway, Denmark, New Zealand, Australia,
Canada, Romania, England/Wales, and the Netherlands. The Nordic
Arthroplasty Register Association (NARA) is a collaboration among the
knee and hip registries of Sweden, Norway, and Denmark. There is a
movement, promoted by the International Society of Arthroplasty
Registries and the FDA’s International Consortium of Orthopaedic