Of the nearly 800,000 total knee replacement surgeries performed annually in the U.S., 88% are still performed manually – putting patients at risk from potential human errors and potentially longer recovery times. Then there are the implants. Many implants used today are "one-size-fits-none," which don't fit all patients perfectly. Today’s major problems in joint replacement include mechanical loosening, bone loss, dislocation, ease of revision and fracture. About 100,000 hip and knee replacements fail every year, and 36% of patients regret their procedure altogether. 

AI is helping address these challenges, speeding up surgeries and potentially improving patient outcomes. By analyzing patient data – including patient records and medical images – AI can assist surgeons in providing patients with precise and accurate diagnoses, identifying patterns or abnormalities that would be difficult to spot with the human eye. In the planning stage, in the future AI could help give surgeons valuable insights regarding where to place the implants and how to better predict surgical outcomes. Artificial intelligence can also help surgeons in the operating room with robots leveraging AI-powered preoperative planning that provides real-time guidance to efficiently cut bone for precise and accurate implant placement. Let's not forget the recovery stage – even there, AI could prove useful in the future to potentially help surgeons develop customized treatments by analyzing the range of motion, muscle strength and gait of the patient.

Monogram Orthopedics Inc. (NASDAQ:MGRM) will be using AI (machine learning) and robotics to deliver the next generation of patient care and improve implants to improve fit and capital efficiency. The Austin, Texas-based medical device company is at the cutting edge, betting that customizing implants to the unique needs of patients will go a long way in improving outcomes for the countless people who need hip and knee replacements each year – with machine learning algorithms that could identify the critical anatomical landmarks to help inform the implant design. These technologies are not yet commercial or FDA-cleared.

"Our mission is to make orthopedics personal. The current standard of care is highly impersonal," says Monogram CEO Benjamin Sexson. "In crude terms, patients are permanently and irreversibly amputating arthritic bone to have it replaced with an off-the-shelf generic implant that, in non-clinical terms, gets ‘hammered' into place. Simplistically our goal is to replace joints with implants that are designed for a more personalized fit and placed with advanced robotics. We are working to mitigate the risks of arthroplasty with technology that drives personalization."

Monogram is aiming to revolutionize orthopedics with the launch of its robotic technology mBôs, which links 3D printing and robotics with advanced pre-operative imaging. The robots aim to help surgeons plan where to place the implant to achieve target laxity values under stress. Accompanying the robot are "best fit" implants that the company believes could improve the personalization of what is available today.  

The idea is to get to a point where surgeons use 3D-printed implants that are designed based on the patient's unique characteristics. The custom implants could reduce the need to carry excess inventory and would be press-fit (they wouldn't need cement to hold them in place). Monogram's robots are designed to precisely cut the bone to help surgeons place the custom implants on the patient. With more of the patient’s bone preserved, this could result in a more bone-sparing design. Using the Monogram software platform and product solution architecture powered by AI and machine learning, the vision is for surgeons to be able to design optimized implants that they anticipate could improve stability and physiological loading. The company is researching the potential benefits of its designs and has not conducted clinical trials. Quick-build 3D printing could also enable maximum logistical and clinical efficiency, enabling clinical representatives to process patient image data using industry-leading machine learning algorithms and automated processes, says Monogram. This could reduce case processing time, lowering the cost of surgery. 

"Bone is a composite. It consists of compact bone at the periphery, spongy bone and bone marrow. Our implants are designed to maximize contact with the inner cortical wall (inner surface of the compacted bone at the periphery) to improve initial stability," says Sexson. "The primary purpose of the machine learning algorithms is to segment bone (inner and outer cortex) from the CT scans as well as to identify the critical anatomical landmarks that inform the implant design algorithms."

Monogram is leaning heavily into AI. With Monogram's technology, surgeons could get efficient case planning, fast registration and efficient cutting. Monogram has indicated it will be largely complete with its verification and validation in the first half of 2024, with a planned 510(k) application submission for FDA clearance in the second half of 2024.

Technological advancements like AI are transforming healthcare, particularly when it comes to joint replacement surgeries, and for good reason. Today's approaches are antiquated, generic, and can be ineffective (20% of patients aren't satisfied with their knee replacement). Monogram hopes it can change that, leveraging technology to personalize what has been a non-personalized procedure to date.