M.A.R.I.O is a cutting-edge platform technology designed for seamless surgical navigation. Once the patient's medical image is uploaded to our portal, we take care of everything—including image processing and navigation model training. The user simply needs to load the prepared model onto their smartphone just before surgery. During the procedure, they can effortlessly follow on-screen guidance to determine the optimal pin placement for securing the standard cutting jig. With no waiting time, a hassle-free workflow, and complete flexibility, M.A.R.I.O streamlines the surgical process like never before.

The M.A.R.I.O system offers a cutting-edge, cost-effective solution with numerous advantages that enhance both surgical efficiency and accessibility:

• Intra-operative Flexibility: M.A.R.I.O provides unparalleled flexibility during surgery, adapting to various procedural requirements.
• Affordability and Accessibility: Offering a cost-effective alternative to expensive robotic systems and patient-specific instrumentation, M.A.R.I.O. increases accessibility to high-quality care globally.
• Universal Compatibility: By utilising standard smartphones, M.A.R.I.O ensures seamless integration with existing healthcare infrastructures, making it accessible to a wide range of medical facilities.
• Real-time Ligament Balancing: Incorporating real-time ligament balancing, M.A.R.I.O addresses a critical gap in low-cost navigation technologies, optimizing alignment during procedures.
• Improved Surgical Outcomes: M.A.R.I.O. enhances alignment accuracy and ligament balancing, contributing to better surgical outcomes, reducing complications, and potentially lowering the need for costly revision surgeries.

• Know-how Statistical Shape Model
• Know-how Surgical Navigation

• Patent Italian patent
• Patent Phone handle
• Patent Universal cutting jig attachment
• Patent Ligament balancing

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We have implemented a robust testing protocol and conducted usability assessments involving surgeons using device design #1. Participants provided valuable feedback through questionnaires, as outlined in our testing methodology. Both average location and angular errors exceeded clinically acceptable thresholds, set at 3 mm for location and 3° for angular error. This real-world usage and feedback collection process unveiled key insights.

During these usability assessments, it became evident that the pilot holes designed for the installation of referential pins in design #1 were too loose, causing difficulties for the participants during the surgery. In response to this feedback, we made substantial improvements in our design approach, leading to the development of design #2.
The results obtained with design #2 demonstrated remarkable improvements in performance compared to design #1. Errors in location and angular measurements consistently fell below the clinically acceptable thresholds, with significantly reduced variations between data points. Notably, location errors consistently remained below the 3 mm threshold, aligning with clinically accepted standards. While the sagittal plane exhibited slightly larger errors compared to the transverse plane, the overall average error remained within acceptable clinical limits.

Our rigorous laboratory validation process conclusively affirms the efficacy of the M.A.R.I.O device. Its capacity to achieve implant alignment with remarkable accuracy has the potential to revolutionise total knee arthroplasty procedures, offering the prospect of reduced complications and improved patient well-being. This technology stands as a game-changer in the field, enhancing surgical outcomes and marking a significant advancement in orthopaedic care.