World’s First X-Ray-Based Patient Specific Instrument System for TKR Surgery Gains CE Mark

Zimmer Biomet Holdings, Inc., a provider of musculoskeletal healthcare, has introduced its X-ray-based Patient Specific Instrument, X-PSI Knee System, which is the world’s first CE Marked surgical planning system that allows for patient specific implant positioning solely utilizing X-ray technology. X-PSI Knee System, for use with Zimmer Biomet’s flagship total knee brands, allows surgeons to use X-ray images to generate three-dimensional anatomic models. Zimmer Biomet’s Patient Specific Instruments Planner is then used to view the patient’s anatomy and develop a 3D customized surgical plan. That plan is used to manufacture patient-specific guides and bone models intended to improve implant fit and placement accuracy. This new generation of Zimmer Biomet Patient Specific Instruments can now leverage standard of care preoperative X-ray imaging instead of Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT) scans.
 
“The use of innovative preoperative planning to enable patient-specific customization has the potential to become the gold standard in joint replacement care; however, its widespread clinical utility has been limited by its reliance on MRI and CT imaging, which are less accessible and not typically used for preoperative evaluation,” said Dan Williamson, Zimmer Biomet’s Group President, Joint Reconstruction. “Conversely, virtually every candidate for joint replacement surgery undergoes X-ray imaging, so we are thrilled to debut the first CE Marked, X-ray-based Patient Specific Instrument System, and extend the benefits of customized surgical planning to joint replacement patients across the European Union. This new offering was conceptualized and developed in collaboration with Dr. Mohamed Mahfouz, Professor of Biomedical Engineering at the University of Tennessee, who pioneered the original concept.”
 
X-PSI Knee System, the company’s fourth patient specific guide offering in its Personalized Solutions franchise, will be initially launched in five countries across the European Union.
 
“The growing use of MRI and CT-based planning software to customize implant placement has meaningfully improved patient outcomes in joint replacement surgery^1-5,” said Raju S. Ghate, M.D., lead investigator of the X-PSI Knee System Investigational Device Exemption study, and a practicing orthopaedic surgeon at NorthShore University HealthSystem in Evanston, Ill. “Our study⁶ found that X-PSI Knee System, which uses X-ray imaging with Zimmer Biomet’s Patient Specific Instruments Planner, yields comparably high implant placement accuracy as MRI and CT-based systems, while significantly improving accessibility and clinical utility to a broader patient population.”
 
References
¹ Kassab, S., Pietrzak, W. Intraoperative Benefits of Signature Personalized Patient Care in Total Knee Arthroplasty. White Paper. 2012.
² Lombardi, A., Berend, K., Adams, J. Patient-Specific Approach in Total Knee Arthroplasty. Orthopedics, 31(9), 927-930. 2008. doi:10.3928/01477447-20080901-21
³ Schotanus, M., Boonen, B., Kort, N. Patient specific guides for total knee arthroplasty are ready for primetime; World J Orthop 2016 January 18; 7(1): 61-68 ISSN 2218-5836
⁴ Silva, A., Sampaio, R., Pinto, E. Patient-specific instrumentation improves tibial component rotation in TKA. Knee Surgery, Sports Traumatology, Arthroscopy, 22(3), 636-642. 2013. doi:10.1007/s00167-013-2639-0
⁵ Ng, V., et al. Comparison of custom to standard TKA instrumentation with computed tomography. Knee Surgery, Sports Traumatology, Arthroscopy. 2013. DOI 10.100/s00167-01302632-7
⁶ Data on File at Zimmer Biomet. Protocol No. CSU2015-12K.