Surgical prevention of femoral neck fractures in elderly osteoporotic patients: a randomised controlled study on the prevention nail system device
Autor: | Eugenio Chiarello, Antonio Mazzotti, Cesare Faldini, Guiseppe Tedesco, Sandro Giannini |
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Přispěvatelé: | Giannini S., Chiarello E., Mazzotti A., Tedesco G., Faldini C. |
Rok vydání: | 2018 |
Předmět: |
surgical prevention
Male medicine.medical_specialty Time Factors Time Factor Osteoporotic Fracture Osteoporosis 030209 endocrinology & metabolism Bone Nails Femoral Neck Fractures Follow-Up Studie law.invention 03 medical and health sciences Absorptiometry Photon Postoperative Complications 0302 clinical medicine Randomized controlled trial law Health care medicine Humans Orthopedics and Sports Medicine 030212 general & internal medicine Aged DXA Aged 80 and over Bone Nail femoral neck fracture Femur Neck business.industry Incidence Osteoporosi medicine.disease medicine.anatomical_structure Italy Physical therapy Nail (anatomy) Female Surgery business Osteoporotic Fractures Follow-Up Studies Human |
Zdroj: | HIP International. 28:78-83 |
ISSN: | 1724-6067 1120-7000 |
Popis: | 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. |
Databáze: | OpenAIRE |
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