Cephalomedullary nails in the treatment of high-energy proximal femur fractures in young patients: a prospective, randomized comparison of trochanteric versus piriformis fossa entry portal.

OBJECTIVE: The purpose of this study is to compare a cephalomedullary nail that uses a piriformis fossa starting point to one that uses a trochanteric starting point, in the treatment of high-energy proximal femur fractures in young patients. Our hypothesis was that a nail that uses a trochanteric starting point would result in less blood loss than a nail that uses a piriformis fossa starting point.
DESIGN: Prospective, randomized.
SETTING: Level 1 trauma center. PATIENTS: Thirty-four consecutive patients aged between 18 and 50 years who sustained a subtrochanteric, intertrochanteric, or ipsilateral femoral neck/shaft fracture due to a high-energy injury were enrolled. INTERVENTION: Patients were randomized to have their fractures repaired with a Russell-Taylor Recon Nail or Howmedica Long Gamma Nail. Surgery was performed on a fracture table, in supine or lateral position according to the surgeon's preference. Direct fracture exposure was avoided. Reduction was obtained through traction, patient positioning, and manual pressure. If necessary, stab-wound incisions were made to introduce instruments to improve reduction. Intramedullary reamers were used, and all nails were statically locked. Bone grafting was not used. MAIN OUTCOME MEASURES: Blood loss, incision length, duration of surgery, and body mass index were recorded for each patient. Surgeon's assessment of ease of use of the device and quality of reduction were noted. Patients were to be followed up to assess fracture union. Hip and knee ranges of motion at latest follow-up were measured. Radiographs obtained at the time of union were assessed for varus malalignment. Return to work status was recorded, and the Harris Hip Score was used to assess hip function.
RESULTS: There were 17 patients in each group. The 2 groups did not differ with regard to blood loss, incision length, and duration of surgery or intraoperative complications. Body mass index was significantly linked to duration of surgery (P<0.001) and incision length (P<0.001). Surgeon's assessment of ease of use and reduction quality for the two devices did not differ. The rate of varus malunion did not differ between the 2 groups. Two patients were lost to follow-up before fracture union. All other fractures healed with no need for bone grafting or other procedures to obtain union. One obese patient developed a wound infection that resolved after debridement and a course of antibiotics. A total of 6 patients were lost prior to their 1-year follow-up visit. Among the remaining 28 patients, at an average follow-up of 14 months, no difference was noted between the 2 groups with regard to return to work status, Harris Hip Score, or hip and knee ranges of motion.
CONCLUSIONS: Both devices yield predictably good results in these difficult fractures. We found no difference between the two devices with regard to incision length, duration of surgery, blood loss, reduction, ease of use, union rate, complication rate, or outcome.

RCT Entities:   Population Interventions Outcomes