Sat., 10/10/09 Knee/Tibia, Paper #88, 4:49 pm OTA-2009
Randomized, Prospective Comparison of Plate versus Intramedullary Nail Fixation for Distal Tibia Shaft Fractures
Heather A. Vallier, MD (7-OREF, Synthes); Beth Ann Cureton, BS (7-OREF, RJOS, Zimmer);
Brendan M. Patterson, MD (7-OREF);
MetroHealth Medical Center, Cleveland, Ohio, USA
Purpose: High rates of malalignment have been reported after intramedullary stabilization of distal tibia fractures. Tibial nails have also been associated with knee pain in several studies. Historically, plate fixation of these fractures has resulted in increased risks of infection and nonunion. However, minimally invasive techniques have improved some of these problems. The purpose of this study was to compare plate and nail stabilization for distal tibia shaft fractures, by assessing early and late complications, secondary procedures, and functional outcomes. We hypothesized that nails would be associated with more malalignment and knee pain, and that plates would be associated with pain from hardware prominence.
Methods: 104 patients with extra-articular distal tibia shaft fractures were treated at a Level 1 trauma center. All fractures were located between 4 and 11 cm of the plafond (OTA classification 42A). Patients were randomized to treatment with a reamed intramedullary nail (n = 56) or standard large-fragment medial plate (n = 48). Patients had a mean age of 38 years (range, 18-95) and a mean ISS of 14.3 (range, 9-50). The majority were high-energy injuries. 41 fractures (39%) were open. 27 of the 100 concomitant fibula fractures were stabilized. Complications, secondary procedures, and work ability were evaluated after a minimum of 12 months. Knee pain, Foot Function index and Musculoskeletal Functional Assessment questionnaires were completed.
Results: The 2 treatment groups were evenly matched with respect to age, gender, ISS, fracture pattern, and presence of open fracture. Six patients (5.8%) developed deep infection, with equal numbers in the 2 groups. 83% of infections occurred after open fracture (P <0.001). Four patients (7.1%) developed nonunion after nailing, versus 2 (4.2%) after plating (P = 0.25). Primary angular malalignment of ≥5° occurred in 11 patients with nails (20% of all nails) and 4 with plates (8.3% of all plates; P = 0.03 for plates vs nails). Five additional patients experienced malalignment due to immediate weightbearing against medical advice. Valgus was the most common deformity (n = 15). Malunion was more common after open fracture (55%, P = 0.004). 90% of patients with malalignment after nailing did not have fibula fixation. 11 patients had 15 secondary procedures after plating, 5 of which were for prominent implant removal. This was not significantly different from patients treated with nailing: 9 patients had 13 procedures, 4 for prominent implant removal.
Conclusions: High primary union rates were noted after surgical treatment of distal tibia shaft fractures with both plates and nails. Rates of infection, nonunion, and secondary procedures were similar when the 2 groups were compared. Open fractures were associated with increased rates of infection and malunion. Intramedullary nailing was associated with more malalignment versus plating. Fibula fixation may facilitate anatomic 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.
Disclosure: (n=Respondent answered 'No' to all items indicating no conflicts; 1=Board member/owner/officer/committee appointments; 2=Medical/Orthopaedic Publications; 3=Royalties; 4=Speakers bureau/paid presentations; 5A=Paid consultant or employee; 5B=Unpaid consultant; 6=Research or institutional support from a publisher; 7=Research or institutional support from a company or supplier; 8=Stock or Stock Options; 9=Other financial/material support from a publisher; 10=Other financial/material support from a company or supplier).
• 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. Δ OTA Grant