Abstract
The aim of this study was to compare the clinical and radiographic results of a interlocking nail with a releasing antibiotic core of PMMA with a standard interlocking nail for the treatment of open fractures of the tibia.
Prospective, controlled trial, randomized by surgeon preference, including 30 patients with open fractures of the tibia. Patients were divided into two groups according to the treatment method: Group I (STD), consisting of 14 patients treated by delayed interlocking standard nailing, after an antibiotic treatment and bed rest. Group II (SAFE) comprising 16 patients treated with a interlocking intramedullary nail with a core of PMMA cement with antibiotics, 5 of which had a temporary stabilization with an external fixator. Antibiotics chosen to impregnate the SAFE nail in cases without prior bacteriology were vancomycin (2gr) and flucloxacillin (2gr)
There were no statistically significant differences between groups with respect to demographic data (age, gender), type of fracture and degree of exposure (p>0,05). The mean follow-up was 2.4 years (5 months to 4 years) for the STD group and 2.1 years (4 months to 3 years) for the SAFE group. 15 of the 30 patients had positive bacteriology, including 13 cases with aggressive agents predominating Enterobacter, Enterococcus, Pseudomonas and MSSA groups.
The infection rate after nailing was 43% (6/14 patients) for the STD group and 6% (1/16 cases) to the SAFE group, a statistically significant difference (p=0.02)
The mean time to union was 7.5 months (3 months to 1.5 years) for the STD group and 4.5 months (2 months to 8.5 months) for the SAFE group, a statistically significant difference (p=0.02). The complication rate was 64% (9/14) in the STD group and 25% (4/16) for the SAFE, including a infection rate of 43% in the STD group and 6% in the SAFE group, a statistically significant difference (p=0.03).
We observed that the open fractures of the tibia treated with SAFE nails presented a statistically significant lower rate of infection, faster consolidation and fewer complications compared with treatment with deferred standard nails. Compared to similar devices available on the market, it has the advantage of allowing selection of the type and dose of antibiotics, it allows fixation with screws of intermediate bone segments, it shorten the period of hospitalization and treatment time, reducing the costs associated with the treatment of this pathology
