OrthAlign Inc.’s handheld navigation device for use with both total hip and total knee arthroplasty surgeries has received clearance from the FDA.
FDA Clears OrthAlign’s Handheld Navigation Device
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Called the OrthAlign Plus, the palm-sized, single use computer-controlled navigation device is an alternative for surgeons, specifically in total hip arthroplasty, according to Nick van der Walt, OrthAlign’s vice president of engineering. He said, “Many surgeons have shared with us their challenges in being able to consistently position the acetabular cup at the desired inclination and anteversion. We are now uniquely able to provide surgeons with the tools they need to address those challenges and dramatically improve total hip arthroplasty alignment.”
Company officials report that for total hip arthroplasty surgery, the OrthAlign Plus system provides measurement accuracy of ±3°, with at least 95% confidence when measuring the angle of the shell impactor, relative to the frame of reference defined by the registered landmarks.
“Cup orientation with conventional instruments has been challenging. While navigation systems have been available for over a decade and are known to improve accuracy, adoption has been low due to high capital equipment cost and disruption to surgical workflow. The OrthAlign Plus system provides comparable accuracy without these drawbacks, ” said David J. Mayman, M.D., clinical co-director of the Computer Assisted Surgery Center, Hospital for Special Surgery, New York.
According to the company press release, its product called KneeAlign 2, is fully integrated into the OrthAlign Plus system thus providing a reliable and efficient alternative to expensive computer assisted surgery (CAS) systems. KneeAlign has successfully been used in over 12, 000 total knee arthroplasty cases, demonstrating its accuracy to be comparable to traditional CAS systems, while providing better accessibility through greater ease of use, no need for capital investment, and significant lower cost per case. OrthAlign is a privately held medical device company.
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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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