Dual-Component Intramedullary Implant Versus Kirschner Wire for Proximal Interphalangeal Joint Fusion: A Randomized Controlled Clinical Trial.

We undertook a multicenter, parallel treatment arm, randomized controlled trial to compare the outcomes after surgery for the treatment of lesser digital hammertoe using either a Kirschner wire or a 2-piece intramedullary, stainless steel implant for fixation of the proximal interphalangeal joint. Our primary aim was to compare the incidence of arthrodesis and complications, and our secondary aim was to compare the subjective foot-related outcomes measured using the Bristol Foot Score and the Foot Function Index, stratified by fixation group. We hypothesized that the use of the dual-component implant would result in greater patient satisfaction, a greater incidence of radiographic arthrodesis, and fewer complications after hammertoe repair. The overall mean age of the participants was 58.72 ± 13.48 (range 18 to 84) years, their mean body mass index was 30.14 ± 6.55 (range 20.7 to 46.98) kg/m(2), and no statistically significant differences in the demographic variables were present between the treatment groups at baseline or during the follow-up period. Of the 91 participants, 46 (50.55%) were randomly allocated to the Kirschner wire group and 45 (49.45%) to the intramedullary implant group. No statistically significant differences were observed between the 2 fixation groups in the incidence of complications; however, the 2-piece intramedullary implant group was associated with a greater mean Bristol Foot Score and Foot Function Index score and a greater incidence of fusion.

RCT Entities:   Population Interventions Outcomes