Negative Findings from Level-I Trial Still a Step Forward

Donor-site morbidity from harvesting autologous bone graft has driven the decades-long search for a substitute that performs at least as well as a patient’s own bone. Much of the clinical research on donor-site morbidity is flawed by detection bias, but other factors such as operating-room time and expense are still driving the search for the ideal substitute for autologous bone. Still, the discovery of an ideal bone-graft substitute continues to be elusive.

In The November 6, 2019 issue of The Journal, Myerson et al. report findings from a Level-I trial that investigated the use of adipose-derived cellular bone matrix (ACBM) as a graft substitute in patients undergoing subtalar arthrodesis. Among 57 patients who received autograft and 52 who received ACBM, the substitute delivered lower fusion rates as determined by both CT and plain radiographic/clinical evaluations at 6 months. In addition, patients treated with autologous bone graft had lower rates of serious adverse events.

I commend the authors and funders (AlloSource) of this well-designed clinical trial for reporting these negative results, because it is often just as important to know what doesn’t work as what does. (This manuscript was submitted even after AlloSource decided to halt further production of its ACBM product in 2017.) Such transparent reporting saves other investigators and graft substitute-focused companies from going down similar avenues of investigation. Perhaps even more importantly, publishing negative results such as this might save patients from undergoing procedures with similar formulations that would probably have minimal chance of helping and could do harm.

By contributing to the scientific “process of elimination,” this study brings us one step closer to the identification of a worthy substitute for autologous bone graft.

Marc Swiontkowski, MD
JBJS Editor-in-Chief