Intramedullary repair device against volar plating in the reconstruction of extra-articular and simple articular distal radius fractures; a randomized pilot study.

Abstract

This prospective randomized pilot study reports our institutional experience and early results using Sonoma Wrx (Sonoma Orthopedic Products, Santa Rosa, CA) in the treatment of extra-articular and simple intra-articular distal radius fractures. A total of 64 patients, were enrolled in the study. They were considered eligible if they had; unstable extra-articular distal radius fractures and simple intra-articular distal radius fractures suitable for closed reduction (AO types; A2.2, A2.3, A3.1 C2.1, C2.2). Patients in group I received intramedullary fixation using the Sonoma Wrx device and patients in group II received standard volar locking plate fixation. Radiographic criteria of acceptable healing were used for evaluation. Two groups were similar in terms of baseline characteristics. Mean time of operation was significantly shorter in Group 1 vs. in group 2 (36.81 ± 7.11 vs. 48.97 ± 5.9 minutes, p = 0.001). Time to healing of the fracture was not different between two groups (5.45 ± 1.09 vs. 5.70 ± 1.04 weeks for Group 1 vs. 2, respectively p = 0.36). Overall complications occurred in 9 patients in group 1 and in 15 patients in group 2 (p = 0.17). Follow-up was completed in all patients with a median time of 12 months and 13 months in group 1 and 2, respectively. On radiographic evaluation radial inclination, radial height and volar tilt were not significantly different between group 1 and 2, respectively. There were no significant differences between two groups in regard to wrist rotational degrees measured in last follow-up visit. Sonoma Wrx Device is reliable and effective in terms of achieving satisfactory outcomes in treatment of distal radius fractures. It may be reasonable to use this device to prevent complications that are related to extensive soft tissue dissection.