Clinical Trial
Journal Article
Multicenter Study
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Standardised cement augmentation of the PFNA using a perforated blade: A new technique and preliminary clinical results. A prospective multicentre trial.

Injury 2011 December
Pertrochanteric fractures are a rising major health-care problem in the elderly and their operative stabilisation techniques are still under discussion. Furthermore, complications like cut-out are reported to be high and implant failure often is associated with poor bone quality. The PFNA(®) with perforated blade offers a possibility for standardised cement augmentation using a polymethylmethacrylate (PMMA) cement which is injected through the perforated blade to enlarge the load-bearing surface and to diminish the stresses on the trabecular bone. The current prospective multicentre study was undertaken to evaluate the technical performance and the early clinical results of this new device. In nine European clinics, 59 patients (45 female, mean age 84.5 years) suffering from an osteoporotic pertrochanteric fracture (Arbeitsgemeinschaft für Osteosynthesefragen, AO-31) were treated with the augmented PFNA(®). Primary objectives were assessment of operative and postoperative complications, whereas activities of daily living, pain, mobility and radiologic parameters, such as cement distribution around the blade and the cortical thickness index, were secondary objectives. The mean follow-up time was 4 months where we observed callus healing in all cases. The surgical complication rate was 3.4% with no complication related to the cement augmentation. More than one-half of the patients reached their prefracture mobility level within the study period. A mean volume of 4.2ml of cement was injected. We did not find any cut-out, cut through, unexpected blade migration, implant loosening or implant breakage within the study period. Our findings lead us to conclude that the standardised cement augmentation using the perforated blade for pertrochanteric fracture fixation enhances the implant anchorage within the head-neck fragment and leads to good functional results.

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