The questions surgical robots still need to answer


Robots have transformed many industries, but will they revolutionize healthcare the way some medical device companies and surgeons say they will?

The benefits of robots in orthopedics are widely known — improved precision, fewer complications, reduced surgical times, etc. — but time will tell if they will truly become a surgical game changer.

"A robot can help me put in a knee replacement more accurately than I can put it in with traditional mechanical alignment instruments. What it hasn't been really proven to do though is to improve patient-reported outcomes," Ed Hellman, MD, president and interim CEO of Indianapolis-based OrthoIndy, told Becker's. "It doesn't make your knee work better and it hasn't been around long enough to prove that it makes your knee last longer."

Robotic-assisted procedures significantly increase the cost of surgery, and in the current healthcare climate, Dr. Hellman said it's difficult to justify the cost of advanced technology unless it has been proven to improve outcomes.

"Will a robotic knee replacement allow you to go run the Chicago marathon? Will it decrease the number of people that are dissatisfied with their surgery?" he said. "Right now, we can't make those claims because we don't know that it will."

As has been the case in the past, marketing can get in front of the science in many areas of orthopedics — such as laser spine surgery and stem cell-based products that have not been approved by the FDA — which can result in significant steps backward.

"I don't think there's any way in which robotics will be less effective or worse, but it is more expensive, so before it's truly disseminated through the healthcare system, I think we need to prove what it can and cannot do," Dr. Hellman said.

Robotics has a bright future in orthopedics, but challenges such as the size and cost of devices need to be addressed, and the same holds true for the data to back up manufacturers' claims.

While robotics has become a buzzword in the orthopedics space, stem cells have begun picking up steam despite no related therapies having been licensed or approved by the FDA.

Over the past five years, the number of businesses and medical clinics advertising stem cell-based therapies has multiplied by more than four times to 1,480 businesses operating 2,754 clinics, according to a study published in Cell Stem Cell on Nov. 4.

"Stem cells may very well be a treatment for arthritis some day, but right now we don't know how stem cells should be prepared, we don't know how those preparations should be used and we don't know exactly who they'll help and who they won't help," Dr. Hellman said. "So to me, to go to a clinic that's going to charge you several thousand dollars to do a stem cell injection is a mistake."

Patients are spending thousands on stem cell-based products. with out-of-pocket costs ranging from $1,200 to $28,000, according to the study published in Cell Stem Cell. Without a deep pool of data, any such product can pose risks to patients.

"Joint replacement works. If you're 65 years old and have a worn-out joint, I can look you in the eye and tell you exactly what you can get out of that joint replacement, how well it will work for you and what [you] will and won't be able to do with it," Dr. Hellman said. "And you'll pay less out of pocket with your insurance than you will for a stem-cell injection, where I can't look you in the eye and tell you exactly what it will do for you and what you'll be able to do afterwards."

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