The study, which was conducted in Germany, Norway, and the United Kingdom from 1999 to 2006, involved 165 patients between the ages of 18 and 65 (mean age: 32.6 years old); 80 percent of the patients were men. Patients were randomized to receive either external fixation that was later converted to IM nailing (71 patients) or early definitive IM nailing (94 patients). Before treatment, however, 19 patients (10 from the external fixator group and 9 from the IM group) were excluded due to additional injuries identified in the emergency department. Consequently, the analysis of results was based on intent to treat.


Published 12/1/2007
Annie Hayashi

Traumatic fractures and fixation: A new look from Europe

Careful selection of fixation according to initial assessment strongly advised

Orthopaedic trauma surgeons have struggled to determine the best method and timing for definitive fixation of major fractures in patients with multiple traumas. A 6-year study, conducted in 10 European Level I trauma centers, has concluded that the “the surgical management of the femur fracture [must] be adapted to the clinical condition of the multiple trauma patient.”

According to Hans-Christoph Pape, MD, who presented the results of the study at the Orthopaedic Trauma Association annual meeting, early intramedullary (IM) nailing of the femoral shaft continues to be the “gold standard” for treating polytrauma patients in stable condition. For patients in “borderline” condition, however, using IM fixation for immediate stabilization results in a higher incidence of systemic complications.

Pape, MD

Inclusion criteria presented challenges
Dr. Pape said that the inclusion criteria were particularly challenging. “When you deal with a multitrauma population, how can you define comparable subgroups that give you a comparable subset of patients?” he asked. To be included in the study, the patient had to have a new injury severity score (NISS) in excess of 16 points, or at least three extremity injuries along with a long bone mid-shaft femur fracture that qualified for antegrade IM fixation. Only midshaft femoral fractures were studied.

Patients in unstable or extremis condition, who had very low blood pressure despite fluid therapy, or who had sustained head injuries were excluded. Those with chest trauma who had an abbreviated injury scale (AIS) of less than 2 points were also excluded. Study patients were divided into subsets of “stable” (121 patients) and “borderline” (44 patients), based on their condition. A grading system, based on preoperative tests and scores (hemoglobin levels, revised trauma score [RTS] and NISS), was used to differentiate between stable and borderline patients. Borderline patients had a higher NISS score, as well as other indicators that established their condition as worse than that of the stable patients.

Because analysis showed that patients in the external fixator group had higher RTS and NISS scores, as well as higher head trauma scores, than patients in the IM group, researchers used binary regression analyses on the postoperative outcomes to control for the

differences in severity. They found no significant differences between the two treatment groups in terms of postoperative course and complications after accounting for the group differences in initial injury severity.

Borderline patients results significantly different
“We looked at whether the classification system that we used really separated the stable patients from those who were borderline,” said Dr. Pape. “The majority was stable but the borderline patients were significantly different in most of the parameters, regardless of the method of fixation.

“After adjusting for ISS,” Dr. Pape continued, “the odds of developing acute lung injury (ALI) were 6.69 times greater in borderline patients who underwent IM nailing in comparison with those who underwent external fixation.”

Researchers also noted the following differences between treatment groups and patient subsets:

  • Stable patients who received IM fixation spent less time on a ventilator in comparison with stable patients treated with an external fixator.
  • Borderline patients who were treated with early IM fixation had a higher incidence of ALI than borderline patients who had initial external fixation.
  • Borderline patients, regardless of initial treatment, spent more hours in the intensive care unit and more hours on the ventilator than stable patients.
  • Borderline patients, regardless of initial treatment, were more likely to experience clinical complications such as ALI, sepsis, and multiple organ failure than stable patients.

Final recommendation
Based on all of the findings of this study, researchers concluded that early IM nailing of femoral shaft fractures continues to be the “gold standard,” but that this treatment can lead to a higher incidence of system complications in patients whose clinical condition is borderline.

They issued the following final recommendation: “In patients who present with an unclear status, the type of surgical procedure for fixation of a femoral shaft fracture should be carefully selected, according to the initial assessment of the clinical condition. In borderline patients, an external fixateur should be applied for temporizing purposes.”

The study appears in the September 2007 issue of Annals of Surgery.

Annie Hayashi is the senior science writer for AAOS Now. She can be reached at