So, with all this evidence, why have we published the randomized controlled trial on this topic by King et al. in the April 3, 2019 issue of The Journal? Partly because the authors build upon our knowledge by comparing a relatively new fixation device (a flexible intramedullary locked nail) to a more standard treatment (an anatomically contoured plate). These plate and nail devices are very different from one another in terms of mechanics and surgical technique, and the flexible nail used in this study is much different than the rigid, straight nails or pins that have been used in the past.
A union rate of 100% was observed in both groups, but the authors found that the flexible nail was significantly faster in terms of operative time. (A single surgeon experienced with both devices performed all 72 surgeries.) They also found that the DASH scores between the groups were similar until the 12 month follow-up, at which point the flexible intramedullary nail group had statistically better scores. The authors concede, however, that the 12-month DASH-score difference “might not be clinically relevant.”
There is one other reason why we deemed this article important: The flexible intramedullary device used in this study is substantially more expensive than prior fixation devices that have been shown to effectively treat clavicular fractures. King et al. did not compare device costs, but whenever we study a device that adds to the total cost of care we should attempt to prove that it adds enough patient benefit to warrant the added expense. As the authors conclude, both devices evaluated in this study appear to be effective at treating displaced/shortened clavicular fractures, and there are a number of other factors that both the surgeon and patient should consider (such as surgeon skill and experience and cosmetic results) when deciding which treatment to use.
Marc Swiontkowski, MD
JBJS Editor-in-Chief