A meta-analysis of new generations of knee and hip replacement devices could bode ill for orthopedics makers.
In a study published this week in The BMJ, researchers warned that many innovative new implants may actually have worse durability and safety profiles than their predecessors.
"In this systematic appraisal of the evidence for the commercial introduction of 5 recent, well known and innovative implantable device technologies in orthopaedics, we found no clinically relevant improved benefits for these devices compared with older and established alternative implants," the study authors wrote. "Furthermore, none of these 5 technologies was found to be safer or to have better survival than the established implants."
The researchers, reacting to the high-profile recalls and lawsuits over hip and knee implants, culled through comparative studies of 3 devices used in hip replacements: ceramic-on-ceramic bearings, modular femoral necks, and uncemented monoblock cups. They also dug up studies on devices used in 2 knee replacement procedures: high flexion knee replacement and gender specific knee replacement.
They collected nearly 120 studies encompassing data on more than 15,380 next-generation and older implants used in about 13,160 patients, concluding ultimately that none of the 5 modern implants offered any substantial benefit compared with older generations.
"Our goals are to highlight that the status quo regarding the introduction of new device technologies is not acceptable, that substantial efforts are needed by all stakeholders to invest in systems of careful evaluation and to promote controlled and evidence based introduction of device innovations," the authors wrote. "Combined with recent disasters, we advise that actions should be undertaken by all stakeholders to prevent patients from being further exposed to new device related technologies without proper evidence of improved clinical benefit and safety."