Riassunto dello studio

Fifty-two patients with distal fibula fractures scheduled to undergo an open reduction and internal fixation surgery were randomized to receive a non-locking, one-third semitubular plate with delayed weight-bearing or a polyaxial locking plate plus an early weight-bearing protocol. A total of 45 patients completed follow-up including 25 patients in the semitubular plate group and 20 patients in the polyaxial locking plate group. Primary outcomes of interest included ankle function which was assessed by the the Olerud and Molander ankle score (OMAS), Foot and Ankle outcome score (FAOS), and Karlsson and Peterson Scoring System (KPSS). The secondary outcome of interest included the incidence of complications. Additional outcomes of interest included pain measured on the Visual Analogue Scale (VAS) and range of motion (ROM) (dorsiflexion and flexion). All outcomes were evaluated at 6 weeks and at 3, 6, and 12 months post-surgery, except for ROM which was evaluated at 6 weeks,12 weeks, 6 months, and 12 months. Results of this study demonstrated that OMAS and FAOS scores were statistically significantly improved at both 6 and 12 weeks follow-up in the polyaxial locking plate group vs non-locking plate (p<0.05 for all). Furthermore, KPSS scores were also statistically significantly improved in the polyaxial plate compared to the non-locking plate at 6 weeks (p<0.04) and 6 months (p<0.03) follow-up, but not at the other timepoints. For the incidence of minor complications, 4 cases and 2 cases were observed in the non-locking plate and polyaxial plate groups, respectively. For the incidence of major complications, 2 cases and 1 case were observed in the non-locking plate and polyaxial locking plate groups, respectively. Moreover, no statistical significant differences were observed for ROM dorsiflexion and flexion at all timepoints between the 2 groups (p>0.05 for all).