LifeMOD and Digital Orthopedic Surgery
The paradigm has changed. With nearly a decade of success, medical device manufacturers have now institutionalized computational modeling into the design environment. With powerful tools such as LifeMOD/KneeSIM and LifeMOD/SpineSIM, engineers are now able to consider literally millions of design variations in the same time it took to consider one physical experiment. With this capability, engineers not only consider the impact of geometry, but the relationship between surgical placement errors and patient variations. All at the same time!
In working very closely with medical device manufacturers over the past eight years, we have seen the level of knowledge of the musculoskeletal-device system increase exponentially. It has increased to the point, where engineers are able to predict the ramifications of surgical error, or patient disease states, just by looking at a drawing of a new medical device!
Figure 1. LifeMOD/KneePRO. A surgical simulator for total knee replacements.
Figure 2. LifeMOD/SpinePRO. A surgical simulator for spine surgeons
With this obvious increase in knowledge base in the medical device engineers, the scientists at LifeModeler began considering how this explosion of knowledge can directly affect the wellbeing of the patient. We started looking at the other half of the equation: the surgeon. After discussions with many leading orthopedic surgeons, it became clear that there existed an unmet need in orthopedic surgery: to evaluate the musculoskeletal-device system from a functional level before entering the OR.
Working with our medical device, surgeon and hospital partners we developed a tool which is now in the clinical evaluation stage for both knee and spinal surgeries. These new exciting tools, LifeMOD/KneePRO and LifeMOD/SpinePRO, bring all the power and benefits of accurate, musculoskeletal simulation to the surgeon, in a surgeon-friendly format. We have created a flight simulator for surgeons.
Now, in the matter of several minutes, the surgeon can review the procedure on an Ipad, before entering the OR. Since the digital patient is based on scan and clinical data, the musculoskeletal model is personalized for the particular patient and disease state. The surgeon positions the implant or spinal instrumentation, all the while, considering tissue balancing in the weight-bearing state of the patient.
Since KneePRO and SpinePRO are both based on the industry-leading product development tools, KneeSIM and SpineSIM, the core technology is extremely rigorous and robust. These products are currently under clinical evaluation by several high-volume orthopedic surgeons, several medical device companies and several hospitals. Plans are being formulated to determine the regulatory pathway necessary to deploy the products in the hospital setting. We will have more detail on this as it progresses.
Figure 3. The LifeMOD/SpinePRO process begins by importing a segmented and digitized scan of a particular patient or by selecting a disease condition from a library.
Figure 4. Data for scoliotic patient is imported into LifeMOD/SpinePRO
Figure 6. Instrumentation is specified.
Figure 7. Instrumentation is placed on the model, and rotated to correct the condition
Figure 8. Dynamic trialing is performed to examine the effects of the instrumentation, including examining the flexion/extension, lateral bending and axial rotation
Figure 9. The dynamic outcome is predicted including examining adjacent loadings of the functional spinal units, the range of motion and the bone/screw loading profiles.
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