Biomet, Inc.’s new stemless shoulder is moving and grooving in its first U.S. patient. This inaugural implant of the Comprehensive Nano Stemless Shoulder took place in October at the University of Virginia Medical Center in Charlottesville. The surgery was part of an FDA Investigational Device Exemption (IDE) multi-center prospective clinical study and was performed by Stephen Brockmeier, M.D.
Biomet Implants First U.S. Stemless Shoulder
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“We are excited to be a part of the clinical trial evaluating this potentially significant evolution in shoulder arthroplasty, ” Brockmeier said. “I was impressed with the initial fixation of the stemless implant and was able to perform the shoulder replacement with minimal bone removal and components aligned with the patient’s natural anatomy.”
Another participant in the study is Jonathan Levy, M.D., of Holy Cross Hospital in Fort Lauderdale, Florida. He said, “The procedure using the Comprehensive Nano allows me the potential to accurately restore shoulder anatomy without the limitations created by placing a stem within the humerus. The IDE study will allow us to objectively compare the efficacy of stemless and stemmed prostheses.”
Biomet developed the Comprehensive Nano shoulder based on the clinical heritage of the Biomet T.E.S.S. stemless shoulder, which has been available in European and international markets since its launch in 2004.
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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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