A three-dimensional reconstruction plate for displaced midshaft fractures of the clavicle.

This randomised study compared outcomes in patients with displaced fractures of the clavicle treated by open reduction and fixation by a reconstruction plate which was placed either superiorly or three-dimensionally. Between 2003 and 2006, 133 consecutive patients with a mean age of 44.2 years (18 to 60) with displaced midshaft fractures of the clavicle were allocated randomly to a three-dimensional (3D) (67 patients) or superior group (66). Outcome measures included the peri-operative outcome index, delayed union, revision surgery and symptoms beyond 16 weeks. CT was used to reconstruct an image of each affected clavicle and Photoshop 7.0 software employed to calculate the percentage of the clavicular cortical area in the sagittal plane. The patients were reviewed clinically and radiographically at four and 12 months after the operation. The superior plate group had a higher rate of delayed union and had more symptomatic patients than the 3D group (p < 0.05). The percentage comparisons of cortical bone area showed that cortical bone in the superior distal segment is thicker than in the inferior segment, it is also thicker in the anterior mid-section than in the posterior (p < 0.05). If fixation of midshaft fractures of the clavicle with a plate is indicated, a 3D reconstruction plate is better than one placed superiorly, because it is consistent with the stress distribution and shape of the clavicle.

RCT Entities:   Population Interventions Outcomes