Elsevier

Injury

Volume 42, Issue 12, December 2011, Pages 1484-1490
Injury

Standardised cement augmentation of the PFNA using a perforated blade: A new technique and preliminary clinical results. A prospective multicentre trial

https://doi.org/10.1016/j.injury.2011.07.010Get rights and content

Summary

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 4.2 ml 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.

Section snippets

Materials and methods

The study was performed at nine orthopaedic departments between October 2009 and July 2010. The inclusion criteria were as follows: pertrochanteric fracture (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association, AO/OTA 31A), age 65 years and above, low-energy trauma and signed informed consent. Patients with a pathological fracture, any patients with active malignancy, organ transplantation or infection were excluded. The ethical commission approved the study and every

Results

To investigate the effect of the standardised cement augmentation, 59 patients were analysed. Mean time to follow-up was 4 months (68–355 days). The demographics are shown in Table 1. Associated injuries were noted in two patients. The majority of the patients sustained an unstable pertrochanteric fracture (A2/3; 74.5%). Only 20.3% were independently mobile (Parker Score 9) before their fracture. Mean Parker scores were 4.5 before the fracture and 3.8 at follow-up. At the follow-up, 55.3%

Discussion

The PFNA was proved to be a stable implant for the treatment of proximal femoral fractures.7, 8, 9, 37 Nevertheless, there are complications such as cutting out of the femoral head or blade loosening reported in the literature.7, 8, 9 All these complications are catastrophic failures for these patients due to the necessity of re-operation. As most of these fractures occur in the elderly, these failures are even more severe due to the patients’ co-morbidities and their inability to

Conclusion

The standardised augmentation of the perforated PFNA blade is a safe and user-friendly tool for pertrochanteric fracture fixation. It prevents blade migration within the head–neck fragment and leads to good functional results. These impressions should be proven by a randomised trial comparing the PFNA with and without augmentation.

Conflict of interest

None of the authors has any financial or personal relationship with organisations that could influence their work inappropriately.

Acknowledgements

Synthes is acknowledged for organisational support. There was no involvement of Synthes in study planning, data analysis, interpretation or article writing. The authors would like to thank Dr. Alexander Scola for helping with data management and Dr. Stefanie Erhart for her help with preparation of the article.

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