BACKGROUND: Pin-track complications remain the most troublesome disadvantages of external fixation. The purpose of this study was to compare pin-related complications and pain levels after the use of external fixation for the stabilization of distal radial fractures with pins composed of two different materials. METHODS: In a prospective trail 80 patients (320 pins) with unstable distal radial fracture were randomized for standard small AO-external fixator treatment with the use of identical pin geometry either composed of stainless-steel (Ss) (n = 40) or titanium alloy (Ti6Al4V) (n = 40). The patients were followed at biweekly intervals until the external fixators were removed (44 days after surgery). The patients were evaluated with regard to erythema, drainage, cellulitis, occurrence of pain at each pin-site, clinical or radiographic evidence of pin-loosening, the need for antibiotics, and the need for pin removal before fracture-healing due to infection. RESULTS: The complication rate was 21%, and age was found to be significantly associated with an increased risk of pin-loosening (p = 0.003). There were no significant differences among the two groups with regard to the prevalence of pin-site complications. However, the rate of premature removal of fixator because of severe pin-track infection (5% vs. 0%) and the rate of pin-loosening (10% vs. 5%) was higher in the Ss-pin group. Furthermore, pain values were significantly reduced in the Ti6Al4V-pin group. CONCLUSIONS: The use of Ti6Al4V-pin external fixator in distal radial fractures yields a trend of reduced pin-related complications and significantly reduced pain levels than does the Ss-pin fixator.
RCT Entities:
BACKGROUND: Pin-track complications remain the most troublesome disadvantages of external fixation. The purpose of this study was to compare pin-related complications and pain levels after the use of external fixation for the stabilization of distal radial fractures with pins composed of two different materials. METHODS: In a prospective trail 80 patients (320 pins) with unstable distal radial fracture were randomized for standard small AO-external fixator treatment with the use of identical pin geometry either composed of stainless-steel (Ss) (n = 40) or titanium alloy (Ti6Al4V) (n = 40). The patients were followed at biweekly intervals until the external fixators were removed (44 days after surgery). The patients were evaluated with regard to erythema, drainage, cellulitis, occurrence of pain at each pin-site, clinical or radiographic evidence of pin-loosening, the need for antibiotics, and the need for pin removal before fracture-healing due to infection. RESULTS: The complication rate was 21%, and age was found to be significantly associated with an increased risk of pin-loosening (p = 0.003). There were no significant differences among the two groups with regard to the prevalence of pin-site complications. However, the rate of premature removal of fixator because of severe pin-track infection (5% vs. 0%) and the rate of pin-loosening (10% vs. 5%) was higher in the Ss-pin group. Furthermore, pain values were significantly reduced in the Ti6Al4V-pin group. CONCLUSIONS: The use of Ti6Al4V-pin external fixator in distal radial fractures yields a trend of reduced pin-related complications and significantly reduced pain levels than does the Ss-pin fixator.
Authors: Kai Zheng; Xiaokang Li; Jun Fu; Xiangli Fan; Pan Wang; Yulin Hao; Shujun Li; Hongbin Fan; Zheng Guo Journal: J Mater Sci Mater Med Date: 2011-04-13 Impact factor: 3.896