Prospective randomized comparison of quality of regenerate in distraction osteogenesis of ring versus monolateral fixator in patients with infected nonunion of the tibia using digital radiographs and CT

Aims In this randomized study, we aimed to compare quality of regenerate in monolateral versus circular frame fixation in 30 patients with infected nonunion of tibia. Patients and Methods Both groups were comparable in demographic and injury characteristics. A phantom (aluminium step wedge of increasing thickness) was designed to compare the density of regenerate on radiographs. A CT scan was performed at three and six months postoperatively to assess regenerate density. A total of 30 patients (29 male, one female; mean age 32.54 years (18 to 60)) with an infected nonunion of a tibial fracture presenting to our tertiary institute between June 2011 and April 2016 were included in the study. Results The regenerate mineralization on radiographs was comparable in both groups at two, four, six, and ten months' follow-up but the rail fixator group had statistically significant higher grades of mineralization when compared with the circular frame group at eight and 12 months' follow-up. The regenerate mineralization was also higher in the rail fixator group than in the circular frame group on CT at three and six months, although this difference was not statistically significant. Conclusion Overall, the regenerate mineralization was higher in the monolateral than the circular frame group. A monolateral fixator may be preferred in patients with infected nonunion of the tibia with bone defects up to 7 cm.