Prospective randomized study comparing results of fixation for clavicular shaft fractures with intramedullary nail or locking compression plate

Purpose To reveal whether minimal invasive implantation of a novel intramedullary device produces comparable outcomes with LCP fixation in patients with displaced midshaft clavicle fractures. Methods A prospective randomized two-arm study was performed on patients presenting with Robinson type 2B1 and 2B2 displaced midshaft clavicle fractures with > 2 cm shortening. In group 1 (n = 35, mean age; 42.02 +/- 13.87) patients received minimal invasive intramedullary fixation with Sonoma Crx device (Sonoma, USA) whereas in group 2 (n = 40, mean age; 39.07 +/- 7.04) patients received 3.5 mm locking compression plate (Synthes, USA). Functional assessment was made using range of motion measurement (ROM), constant shoulder score and DASH disability of the arm, shoulder and hand (DASH) scoring. Results Mean time of operation was similar between the two groups (p = 0.46) whereas mean time of fluoroscopy was significantly longer in group 1 compared to group 2 (p < 0.001). At the 12 month follow-up, there was a slight but significant difference in ROM degrees between the two groups (p = 0.005). Mean quick DASH score was significantly lower in group 1 than that in group 2 (p < 0.001) whereas there was no significant difference in constant shoulder scores between the two groups (p = 0.06). Time to bony union was also shorter in group 1 compared to group 2 (p < 0.001). Conclusion Minimal invasive intramedullary implantation technique provided satisfactory clinical outcomes and shortened the time until bony union compared to LCP fixation. Further study on larger populations is required to establish whether the technique offers lower complication rates than LCP fixation.