STRIDE Unicondylar Knee System
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BLUE BELT TECHNOLOGIES, INC Navio™ Surgical Technique Unicondylar Knee System [Blue Belt Technologies] STRIDE Unicondylar Knee System

Blue Belt Technologies Navio System Surgical Technique for use with the STRIDE Unicondylar Knee System [Blue Belt Technologies] (C) 2013 Blue Belt Technologies, Inc. Blue Belt Technologies uses or has applied for the following trademarks or service marks: Navio, NavioPFS, PFS, Handheld Intelligence and the “b” logo. All other trademarks are trademarks of their respective owners or holders. Blue Belt Technologies does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery. Please contact your local Blue Belt...

System and Patient Setup 8 Bone Tracking Hardware 10 Cement Final Components and Close 29 Recovery Procedure Guidelines 30 Manufacturer Contact Information 33

Introduction About this Guide This procedure guide provides an overview of the recommended technique for using the Navio surgical system technology with the STRIDE Unicondylar Knee System. Blue Belt Technologies recommends that the users review this guide prior to performing partial knee replacement surgery utilizing the Navio system. This guide should be used in conjunction with, not replacing, the information contained within the NavioPFS™ User’s Manual that accompanied the purchase of the Navio surgical system. Additional information on the STRIDE Unicondylar Knee System and manual...

Introduction STRIDE System Design Rationale The STRIDE Unicondylar Knee system is a unicompartmental prosthetic device that resurfaces one femoral condyle and one side of the tibial plateau. The femoral component is made of cobalt chrome and the tibial component is made of titanium with a UHMWPE insert that snaps into place. The device is non-constrained; the articulating surface of the UHMWPE insert is flat and joint stability is maintained by ligaments and other soft tissue surrounding the knee. The STRIDE knee system is designed as a system and does not allow the substitution of...

Navio Overview ^^^^^^^^^^ Navio Surgical System Overview The Navio surgical system is a surgical planning, navigation and intraoperative visualization system combined with a hand-held smart instrument for bone sculpting. The camera cart communicates the relative position of the handpiece (cutting tool), the femur, and the tibia (via rigid tracker arrays) to the computer cart, which runs algorithms that control The patient's bone is prepared according to an intraoperative plan that combines soft-tissue and anatomic information with controlled bone removal and predictable long-leg alignment....

Navio Overview Positioning of the System - Position the Navio computer cart so that the surgeon can clearly see and easily operate the graphical user interface at all times. The computer cart should be positioned on the opposite side of the leg to be operated (Figure 5). - The camera cart should be placed on the opposite side of the leg to be operated, approximately 1.5 m from the surgical site and 1.8 m - 2.1 m high. Left-knee OR Setup (above) - Position the operative knee into 90º flexion. Use the laser pointer integrated into the faceplate of the camera head to direct the laser beam at...

System and Patient Setup Preparing the System and Tool - The surgical team will set up Navio to utilize the provided integrated irrigation system (refer to the Preparing the Surgical Drill Irrigation System procedure in the Navio User’s Manual), which will provide continuous irrigation throughout bone removal. - The surgical team will assemble the Navio handpiece using the following recommended tools (refer to the Assemble Tool procedure in the Navio User’s Manual): 6 mm Spherical Bur 6 mm Exposure Control Guard - The surgical team will cover the Navio system touch-screen monitor with a...

System and Patient Setup - Remove intracondylar osteophytes to avoid impingement with the tibial spine or cruciate ligament, as well as peripheral osteophytes that interfere with the collateral ligaments and capsule. In order to reliably assess M/L alignment and joint stability, it is crucial that all osteophytes are removed from the entire medial or lateral edges of the femur and tibia. - Resect the deep menisco-tibial layer of the medial or lateral capsule to provide access to any tibial osteophytes. Exposure can also be improved with excision of patellar osteophytes. - Avoid release of...

Bone Tracking Hardware Placing Tracking Hardware Rigid fixation of the femur and tibia tracking arrays into the bone is critical for a successful Navio surgery. The Navio system utilizes a two-pin bi-cortical fixation system, comprised of the tools pictured in Figure 8. These tools allow for the tracker arrays (Figure 9) to be fixed to the bone and for the tracking spheres to be oriented towards the optical tracking camera. With the operative leg in 90 degrees of flexion, utilize the following procedure: Tibia Tracker Array Placement - Percutaneously place the first bone screw one hand’s...

Bone Tracking Hardware - Slide the Bone Clamp (with the clamp hardware oriented towards the optical tracking camera) over the two bone screws until the bottom of the clamp is within 1 cm of the patient’s skin, taking care not to place the clamp touching the skin. - Clamp the femur tracker array into the bone clamp along the length of the bar on the array, orient the spheres towards the optical tracking camera and slide the array away from the incision site. Confirm Array Visibility Prior to registering the leg with the Navio software, the user must confirm that the position of the optical...

CT-free Registration Navio’s CT-free registration process utilizes standard image-free principles in constructing a virtual representation of a patient’s anatomy and kinematics. The user moves through the software’s workflow via the included Navio system foot-pedal or the touchscreen controls. Any collected point may be re-collected in sequence by moving backwards through the workflow stages. For more detailed information at any stage, press the ‘i’ button found in the upper right corner near the tracker array visibility indicator. Hip Center The Calculate Hip Center stage will follow the...