What’s the Claim?
An RCT in patients undergoing ORIF of proximal humerus fractures that had medial comminution found locked plating alone to be no different from locked plating augmented with a fibular allograft in terms of patient-reported outcomes, pain, ROM, satisfaction, complications, or radiographic parameters (neck-shaft angle or humeral head height). An exploratory subgroup analysis found no difference in the main findings when younger and older patients were compared.
How’s It Stack Up?
Although it’s a no-difference study, it’s an important one. These are tough fractures, and we’re looking for anything that might help. Prior to this RCT, it seemed like these allografts might be the ticket. Indeed, coming into this trial, the best information we have on the topic came from a meta-analysis that said exactly that. Those authors wrote that augmenting these ORIFs with a fibular allograft delivers better radiographic outcomes, improved ASES scores, and decreased odds of a major complication when compared with patients treated with a locked lateral plate alone. However — and this is critically important — all of the source studies in that meta-analysis were retrospective, and only two of the 10 studies they pooled followed patients out for two years. Another key finding of that meta-analysis the authors should have mentioned was that the differences in outcomes scores they observed favoring use of fibular allograft were quite small indeed, likely smaller than what the typical patient might perceive as clinically important.
What’s Our Take?
This is a great example of why science is not a democracy — in this case, one well-designed trial outmuscles a systematic review of 10 observational studies. Remember, observational studies often suffer from selection bias, transfer bias (short or incomplete follow-up), and assessment bias, and those biases generally don’t offset one another — they’re usually additive, and they tend to make new approaches look better than they actually are. Randomized trials tend to reduce the impact of those biases and tend to diminish our enthusiasm for new or large interventions — which is exactly that happened here. This RCT followed patients for two years, and although there was substantial loss to follow-up between the first and second years of the study, the 95% CIs around the outcomes scores overlapped almost entirely at two years and did not span an effect size large enough to be clinically important. This reassures us that the no-difference finding likely will hold up over time. This finding also is practical; it’s tempting to try to shore up the medial buttress in these fractures with a fibular allograft when we perform locked lateral plating, but this study suggests we may be treating ourselves more than our patients when we do so.
Wang Q, Sheng N, Huang JT, et al. Effect of Fibular Allograft Augmentation in Medial Column Comminuted Proximal Humeral Fractures: A Randomized Controlled Trial. J Bone Joint Surg. 2023;105:302-311.