Randomized, prospective comparison of plate versus intramedullary nail fixation for distal tibia shaft fractures.

OBJECTIVES: Malalignment has been frequently reported after intramedullary stabilization of distal tibia fractures. Nails have also been associated with knee pain in several studies. Historically, plate fixation has resulted in increased risks of infection and nonunion. Our purposes were to compare plate and nail stabilization for distal tibia shaft fractures by assessing complications and secondary procedures. We hypothesized that nails would be associated with more malalignment and nonunion.
DESIGN: Randomized, prospective study.
SETTING: Level I trauma center. PATIENTS/PARTICIPANTS: One hundred four skeletally mature patients with extra-articular distal tibia shaft fractures with a mean age of 38 years (range, 18-95 years) and mean Injury Severity Score of 13.5 (range, 9-50). The majority had high-energy injuries. INTERVENTION: Patients were randomized to a reamed intramedullary nail (n = 56) or a large fragment medial plate (n = 48). Forty fractures (39%) were open. Twenty-eight (27%) had concomitant fibula fractures that were stabilized. MAIN OUTCOME MEASUREMENTS: Malunion, nonunion, infection, and secondary operations.
RESULTS: The two treatment groups were evenly matched with respect to age, gender, Injury Severity Score, fracture pattern, and presence of open fracture. Six patients (5.8%) developed deep infection with equal numbers in the two groups. Eighty-three percent of infections occurred after open fracture (P < 0.001). Four patients (7.1%) developed nonunion after nailing versus two (4.2%) after plating (P = 0.25) with a trend for nonunion in patients who had distal fibula fixation (12% versus 4.1%, P = 0.09). All nonunions occurred after open fracture (P = 0.0007); the primary union rate for closed fractures was 100%. Primary angular malalignment of 5° or greater occurred in 13 patients with nails (23% of all nails) and four with plates (8.3% of all plates; P = 0.02 for plates versus nails). Six additional patients experienced malalignment after immediate weightbearing against medical advice. Valgus was the most common deformity (n = 16). Malunion was more common after open fracture (55%, P = 0.04). Eighty-five percent of patients with malalignment after nailing did not have fibula fixation. Eleven patients underwent 15 secondary procedures after plating, five of which were for prominent implant removal. This was not significantly different from patients treated with nailing: 10 patients had 14 procedures and five for prominent implant removal.
CONCLUSIONS: High primary union rates were noted after surgical treatment of distal tibia shaft fractures with both nonlocked plates and reamed intramedullary nails. Rates of infection, nonunion, and secondary procedures were similar. Open fractures had higher rates of infection, nonunion, and malunion. Intramedullary nailing was associated with more malalignment versus plating. Fibula fixation may facilitate reduction of the tibia at the time of surgery. The effect of fibula fixation on tibia healing deserves further study. Economic assessment and functional outcomes data for this population will help to enhance our treatment decision-making.

RCT Entities:   Population Interventions Outcomes