Thurs., 10/18/07 Femur, Paper #4, 1:25 pm OTA-2007
Restoration of Function and Walking Ability after the Treatment of Trochanteric Fractures with PFNA: Results of a Multicenter Case Series
Hermann J. Bail, MD1 (a-Berlin Charité); Christian van der Werken2 (a-UMC Utrecht);
Rogier K. J. Simmermacher, MD2 (a-UMC Utrecht); Arthur H. P. Niggebrugge, MD3 (a-Bronovo);
Uwe Ochs, MD4 (a-BGU Tuebingen); Thomas Hockertz, MD5 (a-Braunschweig);
Hans G. Clement, MD6 (a-Graz); Beate Hanson, MD7 (e-AO);
1Klinik für Unfall- und Wiederherstellungschirurgie, Universitätsklinikum Charité,
Campus Virchow-Klinikum, Germany;
2University Medical Center Utrecht, Netherlands;
3Bronovo Ziekenhuis, Netherlands;
4Berufsgenossenschaftliche Unfallklinik Tübingen, Germany;
5Unfallchirurgische Klinik Städtisches Klinikum Braunschweig, Germany;
6Universitätsklinik für Unfallchirurgie Graz, Austria;
7AO Clinical Investigation and Documentation, Davos, Switzerland
Purpose: A prospective, multicenter case series was performed to assess the functional outcome and complication potential of proximal femoral nail antirotation (PFNA) in the treatment of unstable trochanteric fractures.
Methods: Patients with AO/OTA 31-A2 or 31-A3 unstable trochanteric femur fractures at 11 study centers were enrolled in the study, operatively treated with the PFNA, and prospectively followed for 1 year. All intra- and postoperative local or general complications were documented and classified as implant- or nonimplant-related. Complication reports were reviewed by an external panel. Additional outcome measures included radiologic assessment of fracture healing, alignment, and implant position. Functional outcome was measured with SF-12 and Parker mobility score, pain with visual analog scale (VAS).
Results: 313 patients with 315 fractures and a mean age of 80.6 years (range, 18-102) were included into the study. After 1 year, the follow-up rate of the surviving patient population was 80%.
Intraoperative complications occurred in 46 patients; the majority (85%) were considered as a result of technical problems, eg, measuring the correct length of the PFNA blade. In total, 165 complications in 118 patients were documented during the 1-year follow-up; they included 46 local complications, among them 4 imminent cut-outs, 2 blade loosenings, 2 blade migrations, 1 nail breakage, 7 refractures at implant location, 8 superficial infections, 2 deep infections, and 5 healing problems. General complications (118/165; 72%) included 28 infections, 12 fractures at another location and 3 thromboembolic complications, and 58 deaths, mainly caused by cardiac failure (59%), general patient weakness, pneumonia, and cancer. The overall 1-year risk for experiencing at least one postoperative complication was 42% (95% confidence interval [CI]: 36.7-47.9) including a mortality rate of 19% (58/313). Only 17 and 5 complications were considered to be definitely or possibly related to the PFNA intramedullary implant, respectively.
Although the Parker Mobility Score significantly decreased at the 6-month and 1-year follow-up examinations (P <0.001), 46.3% and 50.3%, respectively, of the followed patients (n = 87) satisfactorily achieved a similar or even better walking ability when compared to their baseline status. Pain at motion (VAS 0-100) decreased from 22 points at 6 months to 15 points at 1 year.
Conclusions: Despite the high underlying mortality of the fracture itself, the PFNA is capable to restore preoperative function and walking ability. Only a small percentage of complications can be attributed to the new implant.
Significance: The implant is suitable for its use in elderly patients who have experienced an unstable trochanteric fracture.
If noted, the author indicates something of value received. The codes are identified as a-research or institutional support; b-miscellaneous funding; c-royalties; d-stock options; e-consultant or employee; n-no conflicts disclosed, and *disclosure not available at time of printing.
• The FDA has not cleared this drug and/or medical device for the use described in this presentation (i.e., the drug or medical device is being discussed for an “off label” use). ◆FDA information not available at time of printing.