Product Review: Stryker Mako Total Hip 4.0 | TechSci Research


Posted April 30, 2021 by pramod

The robotic technology has brought a tremendous transformational shift in the way surgical procedures are performed, especially when it comes to knee, spine, and hip surgeries.

 
The robotic technology has brought a tremendous transformational shift in the way surgical procedures are performed, especially when it comes to knee, spine, and hip surgeries. Robots have become a preferred choice for orthopaedic practices to overcome the drawbacks of conventional surgeries and enhance patient outcomes. Addressing the challenges of orthopaedic landscape, Stryker’s robotic surgical platform, Mako Total Hip 4.0 has become one of the most popular devices for performing total hip replacement surgeries that deliver value to patients and surgeons. It is currently the only robotic-arm bone preparation system that has the ability to cut with a saw, ream with a reamer and burr with a burr.

The short-term and long-term consequences of total hip arthroplasty (THA) are largely influenced by factors such as patient demographics, surgical techniques, and implant features. One of the most surgeon-controlled factors is component positioning, which has been linked to hip dislocations, poor biomechanics, dislocation, mechanical loosening, leg length discrepancies, accelerated wear and revision surgeries. The Mako system is designed to help reduce the margin of errors associated with component placement and thus enhance the accuracy and reproducibility of total hip arthroplasty.

FDA-approved Mako system integrates three key components such as 3D CT-based planning, AccuStopTM haptic technology and insightful data analytics into one platform. The CT scan creates a 3D image of the unique anatomy of patients to assess the joints precisely, allowing the surgeon to gather a proper understanding about their patient. Mako’s AccuStopTM haptic technology guides the surgeon to cut, replace, and restore the bones as earlier planned. The insightful data analytics platform provides real-time data to assess ligament tension throughout range of motion and implant articulation. Also, the surgeons can prevent inadvertent transaction of vital structures and refine the surgical plan for enhanced soft tissue balance.  Proper implant stability and longevity depends on the amount of bone stock left after acetabular reaming therefore the preservation of acetabular bone is the primary step during THA. Mako Total Hip allows use of small acetabular cups with respect to patient’s femoral head size for greater preservation of bone stock.

Stryker Mako Total Hip 4.0 differentiates from other robotic surgery platforms in terms of accuracy, component positioning, software, and value.

Accuracy

The AccuStopTM haptic technology assists surgeons with executing the created and approved surgical plan, tracking implant positioning, tissue balancing through a virtual 3D model combining a preoperative CT and intraoperative bone registration. While plain film radiographs provide a 2D image of the scanned area that creates a less detailed image, the CT scan produces a more detailed image, eliminating overlapping structures and making internal anatomy convenient to visualize.

Component Positioning

Leveraging AccuStopTM haptic technology, the robotic arms ensures that only desired bone is resected. If the surgeon tries to move the cutting tool on the robotic arm outside the boundaries created in the preoperative plan, then the robotic arm will give resistance, audible warning, and then automatically turn off. The Mako system has the capability to virtually create or modify preoperative plan before making an incision and the surgeon is also able to analyse and modify plan before resecting bones.

Software

The newly built software of Mako Total Hip 4.0 improves the surgeon’s experience with approach-specific and region-based pelvic registration. The new features in the software allow surgeons to plan a patient’s implant positioning taking into account pelvic tilt in patient sitting, standing, and supine positioning. The technology now enables surgeons to visualize the femur-to-pelvis and component relationship for detecting risk of potential impingement. Along with 3D templating, the software now has dynamic range-of-motion modelling and ability to include spine-pelvic motion into planning.

Value

Mako Total Hip 4.0 has the potential to deliver value through enhanced outcomes by reducing pain and use of pain medication, reducing complication, increasing patient satisfaction, reducing utilization of health services, and reducing payer cost. Also, patients can return to their daily activities and expect positive early outcomes.

The Mako’s Haptic technology can become annoying for surgeons during operation as it restricts their control and ability to complete bone cuts. Also, the high cost of the device can limit healthcare institutions to opt for the device.

Pros & Cons of Mako Total Hip 4.0

Pros

Allows surgeons to create detailed personalized surgical plans
Enable surgeons to position implants with absolute precision
Optimizes standard replacement joint prosthesis to match patient’s anatomy
Minimizes excessive stress on soft tissues and ligaments, mapping patient’s natural joint movement patterns intraoperatively
Fewer prosthesis complications post procedure
Shorter rehabilitation times
Enhanced safety
Less chances of implant failures or need for revision
Reduced blood loss
Greater preservation of bone stock

Cons

Require longer surgical time that increases risk of infections
Require appropriate training and experience to achieve optimal final surgical results
Require imaging for pre-operative templating
Costlier procedure
Substantive installation costs
Lack of data showing improved clinical outcomes or implant survival

Other Advanced Robotic Systems for Orthopaedic Surgeries

Think Surgical TSolution-One

ROBODOC (TSolution-One) was the first innovative robotic system designed to perform complicated orthopaedic surgeries (hips and knees) with great precision. The CT scans were converted into three-dimensional virtual images for preoperative planning and computer-guided drilling. ROBODOC name was changed to TSolution-One in 2014 by Curexo Technology Corporation. TSolution-One is an active, autonomous, image-based robotic milling system capable of reproducing accurate component placement leveraging image-based preoperative planning system. The robotic system offers several advantages such as accurate determination of femoral rotational alignment, maintenance of bone temperature with bone milling, and customized femoral rotational alignment.

TSolution-One is an open platform that allows the application of different manufacturer implants based on surgeon’s preference and patient’s convenience. However, there are certain complications associated with robotic system that affects its efficiency. The time taken by the robotic arm to cut the bone is more than what a conventional surgery might take, which leads to additional time of the procedure. The system does not possess the ability to differentiate between different tissue types, so the surgeon needs to move the soft tissues away from the miller to prevent any damage. Also, the robotic system is not cost-effective so many healthcare institutions resist the adoption of TSolution-One and choose its counterparts.

Medtronic Mazor X Stealth Edition

Mazor X Stealth Edition incorporates Stealth software technology into the robotic-assisted surgery platform to deliver flexibility and workflow predictability through interactive 3D planning and information systems for real-time image guidance and visualization. The new technology uses cutting-edge software and robotic arm to guide implants and instruments through the steps of surgical procedure with precision while using real-time imaging feedback. Better spinal instrumentation accuracy and consistency with Mazor Core Technology significantly results in shorter hospital stay with reduction in time spent placing pedicle screws.

Smith & Nephew Navio

Navio is a semi-open, semi-active system that utilizes spatial referencing to generate a visual representation of the hard tissues. Mounting pins are placed on the femur and tibia for intraoperative spatial referencing. Navio is currently the only handheld robotics technology for knee arthroplasty, that offers freedom, accuracy, value, efficiency, and patient satisfaction. The Navio 7.0 operating system delivers a surgical workflow that improves usability and decrease learning curve.

In terms of implant position, both Mako and TSolution-One exhibit excellent accuracy for acetabular positioning as well as femoral offset. Also, Mako prevents excessive reaming or resection that leads to soft tissue impingement, aseptic loosening, and altered hip-centre position by greater preservation of acetabular bone stock. Likewise, TSolution-One improves alignment of the femoral component with no intraoperative features.

Conclusion

The use of robotic assistance for surgeries would continue to expand with the introduction of more technological advances. Lack of training and cost are the two major restraining factors when it comes to robotic systems, so the key players need to address these challenges as the demand for surgeries would grow in the coming years. Besides, further clinical evaluation will be needed to confirm the benefits of the robotic technology and determine its long-term consequences.

According to TechSci research report, “Global Orthopedic Devices Market By Type (Joint Reconstruction Devices, Spinal Devices, Trauma Devices, Ortho-biologics, Others) By Application (Hip Orthopedic Devices, Knee Orthopedic Devices, Spine Orthopedic Devices, Craniomaxillofacial Orthopedic Devices, Dental Orthopedic Devices, Others) By End User (Hospitals & Clinics, Ambulatory Care Centers, Others) By Region, Competition Forecast & Opportunities, 2026”, the global orthopedic market is expected to grow at a significant rate during the forecast period, owing to increasing requirement of medical devices and introduction of advanced technologies in these devices to support modern treatment plans.

According to another TechSci research report, “Global Hip Replacement Devices Market By Product Type (Primary Hip Reconstruction Devices, Partial Hip Reconstruction Devices, Revision Hip Reconstruction Devices, Hip Resurfacing Devices) By End User (Hospitals, Ambulatory Care Centers, Orthopedics Clinics, Others) By Region, Competition Forecast & Opportunities, 2026”, the global hip replacement devices market is expected to grow on account of rising prevalence of osteoarthritis and increasing geriatric population. Besides, rising awareness about health and government regulations for improving the quality of healthcare infrastructure is expected to fuel the global hip replacement devices market.

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Last Updated April 30, 2021