One aspect of being a market leader is that your products may end up competing against each other. That appears to be the case regarding two of Synthes (the market leader in trauma products) hip fixation nails—the company’s trochanteric fixation nail and the trochanteric fixation nail advanced.
Synthes vs Synthes Nails, Who Wins? Hmm…
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The results of this study, titled: “Risk of Revision After Hip Fracture Fixation Using DePuy Synthes Trochanteric Fixation Nail or Trochanteric Fixation Nail Advanced,” appear in the June 15, 2022, edition of The Journal of Bone and Joint Surgery.
An orthopedic surgeon with the Hawaii Permanente Medical Group in Honolulu, Kanu Okike, M.D., M.P.H., was a co-author on the study and explained the idea and purpose behind this unique study to OTW, “The Synthes Trochanteric Fixation Nail Advanced has begun to supplant its prior generation forebear, the Trochanteric Fixation Nail, in clinical usage. However, prior research has raised concerns about the risk of fatigue failure at the proximal screw aperture of the Synthes Trochanteric Fixation Nail Advanced.”
The researchers used data from Kaiser Permanente, a system that covers more than 12 million members in eight regions of the United States. They focused on patients who underwent hip fracture surgery, collecting information on demographics, comorbidities, intraoperative details, implants, and outcomes.
Their retrospective cohort study included individuals who had cephalomedullary nail fixation with a Trochanteric Fixation Nail (4,007) or a Trochanteric Fixation Nail Advanced (3,972). The procedures included in the study were performed by 354 surgeons (35 hospitals). The team defined revision as any operation (at any time after the initial surgery) in which a component was removed and/or replaced.
From 2014-2019, the study time frame, the Trochanteric Fixation Nail was more commonly used until 2016, and then the Trochanteric Fixation Nail Advanced became more commonly used from 2017 to 2019. After three years, the revision rate was 1.8% for the Trochanteric Fixation Nail and 1.9% for the Trochanteric Fixation Nail Advanced
“In this study of nearly 8,000 procedures utilizing the Trochanteric Fixation Nail and Trochanteric Fixation Nail Advanced,” Dr. Okike told OTW, “we found no significant differences in the overall risk of revision. We did, however, find that the risk of revision for nonunion was higher in procedures utilizing the Synthes Trochanteric Fixation Nail Advanced as compared to the Trochanteric Fixation Nail.”
“Surgeons who are currently using the Trochanteric Fixation Nail or Synthes Trochanteric Fixation Nail Advanced may continue doing so, according to their preference. In patients with a particularly high risk of nonunion (such as those with unstable fracture patterns, pathologic fractures, or a smoking history), the Trochanteric Fixation Nail may represent a better choice.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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