Newsletters & Blogs


Sometimes a technical innovation fails to deliver improved patient outcomes.

An example may be robotic-assisted knee replacements.

Robotic-assisted knee replacements, especially using Stryker’s Mako system, have become increasingly common in the U.S. This surge in robotic surgeries signifies a major leap in medical practices.  The promise was to provide improvements in surgical outcomes.

However, the transition has sparked debate over the evidence supporting these procedures’ superiority.  This is particularly the case concerning total knee arthroplasty (“TKA”).

  • 60% of U.S. knee replacements utilize Stryker’s Mako robotic system.
  • Concerns exist over the objectivity of studies due to financial interests.
  • Research shows similar revision surgery rates between robotic and manual TKA.

Crowley Law has deep experience in navigating the legal issues surrounding the development of life sciences and other technologies.  Contact us – [email protected] or (908) 540-6901 – if you need help in structuring your company or operationalizing your development plans.

Now to the analysis . . .

Despite the enthusiastic adoption of the Mako system, skepticism remains.  It is focused on the robustness of evidence backing the enhanced efficacy of robotic-assisted TKA.  Lucas Nikkel from Johns Hopkins Medicine has suggested potential bias in the research, perhaps influenced by financial conflicts of interest.

This skepticism underlines the need for impartial studies to validate the claims of improved precision and recovery associated with robotic surgeries.

In an effort to provide clearer insights, a study leveraging the American Joint Replacement Registry analyzed outcomes of cementless TKAs.  The study focused on a demographic linked to Medicare claims. This approach aimed to bypass biases by examining older patients.

The findings were enlightening.  They showed no significant difference in the likelihood of revision surgeries between patients undergoing robotic-assisted and traditional manual procedures. Such results challenge the anticipated benefits of robotic assistance in knee replacements.

They suggest that these technical advancements may not translate into better early postoperative outcomes as expected.

This revelation underscores the complexity of integrating new technologies into medical practice. It emphasizes the importance of critical evaluation and reliance on unbiased evidence before fully embracing robotic-assisted surgeries.

Crowley Law LLC emerges as a pivotal resource in this context, offering specialized legal guidance on technology development, patent rights and regulatory compliance. Their expertise is invaluable for developers and practitioners involved in the complex world of medical technology. By consulting with Crowley Law LLC, stakeholders can increase that prospects that their contributions to medical advancements are not only innovative but also legally sound and compliant.

The journey toward integrating robotic-assisted surgeries into mainstream medical practice is fraught with challenges, both technical and ethical. As the field continues to evolve, the collaboration between medical professionals, researchers, and legal experts becomes increasingly vital. Together, they can forge a path that leverages technological advancements for the betterment of patient care, ensuring that innovations are grounded in solid evidence and legal integrity. Engaging with firms like Crowley Law LLC is a strategic move for anyone involved in the development and implementation of medical technologies, securing a future where innovations not only enhance surgical precision but also navigate the complex legalities of the healthcare industry.



About the Author

Contact Our Firm