Abstract
Introduction:
Hip fractures represent an enormous challenge for our health care system. The aim of this randomised controlled trial was to assess both efficacy and safety of a novel device called Prevention Nail System (PNS) and developed for the surgical prevention of a contralateral femoral neck fracture (FNF) in elderly osteoporotic patients.
Methods:
Primary outcome was to evaluate, in patients suffering from osteoporotic FNF, the effectiveness of PNS in reducing the incidence of a contralateral hip fracture. Secondary outcome was to evaluate the safety of this device therefore intra- and postoperative complications were recorded.
Results:
72 patients, with an age ⩾65 years old, were enrolled (38 study group (group A) and 34 control group (group B). 3 and 5 contralateral FNF were recorded respectively in group A and B. An interim analysis showed a non-effectiveness of the device therefore enrollment was suspended.
Discussion:
In all group A failures a difficult positioning of the PNS was recorded: surgical techniques errors may have affected the result. Nevertheless, it is improbable to hypothesise that, without substantial modifications to the PNS design, this could significantly reduce the incidence of FNF. Considering that current pharmacological approach can achieve, at best, a marginal reduction in FNF especially in patients at high risk, complementary approaches to provide immediate prevention of hip fractures may need to be developed.
Clinical Trial Protocol:
N° 263. 03 June 2008.
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