This article is more than 5 years old. Information may no longer be current.
Total hip arthroplasty techniques, implants should follow international ‘rules’
Click Here to Manage Email Alerts
 Per Kjærsgaard-Andersen |
It seems like every fifth year or so a new “player” is introduced in the total hip arthroplasty device field. This forces some recognized and proven designs or techniques further into the background.
Within the past 10 or more years, hip surgeons have dealt with new options, such as minimal two-incision total hip arthroplasty (THA) and resurfacing THA, which resulted from a few surgeons’ belief in the procedures and were followed by rapid, large-scale worldwide adoption due to industry launches, increased media focus and the practice of associating recognized surgeons with the techniques and implants.
Following the sudden popularity of two-incision and resurfacing THA, we are well aware of what has happened — early complications, recalled products, few demonstrated long-term benefits vs. the standard, proven and more conventional THA. Some institutions even reported late increases in severe complications. The newest player is the short, non-cemented hip stem with its promoted benefits that are equally appealing to patients — a less invasive, bone-sparing procedure which avoids reaming the medullary canal and improved bone remodeling.
Most companies with total hip implants in their portfolio have developed short stem THA prostheses because not having such an offering could effect their market share. However, the consequence is that there are about 15 short non-cemented stems on the market in Europe now, and some implants have little or no data or science supporting their use. The initial published results typically involve a limited number of patients treated at the designer surgeon’s clinic with no short-term failures reported.
I am concerned about the lack of randomized, controlled studies comparing the new short stem and standard THA implants. The evidence to date, which shows no complications, is based mainly on publication of case-controlled studies with short-term results from cases done only at the designer’s clinic. Innovation and evolution of orthopaedic procedures must continue, but using living human beings to “test” these devices is unethical.
The introduction of new techniques and implants should follow accepted international “rules” before they attain widespread use. We should perform limited case-control studies in just a few clinics; do stem stability studies with a minimum of 3 years follow-up; and conduct randomized studies comparing new implants with proven concepts and do more studies outside the designer’s clinic. Equally important are early assessments of results of short stem implants and related surgical techniques in national implant registers. This is essential to detect the consequences of putting them in the hands of practicing THA surgeons.
We, the hip surgeons, are responsible for ensuring these rules have been followed before we take up a new implant or technique because we are the only ones to blame if anything goes wrong.