91 patients (95 toes) with unilateral hammertoe deformity were randomized to undergo arthrodesis with either a dual-component intramedullary stainless steel (DCIMSS) implant or K-wire fixation. The purpose of this study was to determine if the use of a DCIMSS implant resulted in a significantly improved rate of successful arthrodesis (radiographic fusion), patient-reported pain, function, disability, activity level, and a lower incidence of complications when compared to K-wire fixation over a 6-month follow-up period. A significantly higher incidence of successful union was observed from 6 weeks to 6 months with the DCIMSS implant compared to K-wire fixation. No statistically significant differences between groups were noted in either Bristol Foot Scores or Foot Function Index scores, with the exception of a significantly lower mean BFS in the DCIMSS group versus the K-wire group at 1 week postoperatively.