Evidence Lacking for Efficacy of Implantable Devices
No convincing evidence supports use of five well-known devices for joint replacement
WEDNESDAY, Sept. 10, 2014 (HealthDay News) -- High-quality evidence for the effectiveness and safety of recent and ostensibly high-value implantable devices in major joint replacement is lacking, according to a study published online Sept. 9 in BMJ.
Marc J. Nieuwenhuijse, M.D., from Weill Cornell Medical College in New York City, and colleagues conducted a systematic review to examine the evidence for effectiveness and safety of five recent implantable devices in major joint replacement. Three of the innovations were for total hip replacement and two for total knee replacement. A total of 118 studies met the inclusion criteria and reported data for 15,384 implants in 13,164 patients.
The researchers found that per device innovation, the comparative evidence varied from four low- to moderate-quality retrospective studies to 56 studies of varying quality, including seven high-quality studies. Neither functional nor patient-reported outcomes were improved with any of the five devices. There was no indication of improved device survival in comparative data with well-established alternative devices. Higher revision occurrence was seen in association with modular femoral necks and ceramic-on-ceramic bearings in hip replacement (hazard ratios, 1.9 and 1 to 1.6, respectively) and with high flexion knee implants (hazard ratio, 1.0 to 1.8).
"Improved regulation and professional society oversight are necessary to prevent patients from being further exposed to these and future innovations introduced without proper evidence of improved clinical efficacy and safety," the authors write.