Zimmer Biomet shared data on its smart knee implant at the American Academy of Orthopaedic Surgeons conference on Wednesday.
The company found that patients who used its Persona IQ implant with a care management platform had better outcomes a year after surgery than people with a traditional knee implant.
Mike Anderson, Zimmer’s clinical strategy associate director, said the results of the analysis showed that the company’s technology was associated with lower rates of revision surgery and periprosthetic joint infection, less use of opioids, and fewer visits to urgent care and physical therapy.
“We can’t really say that there is causality in this, but we can say that there is an association between being monitored in these digital care pathways and fewer complications,” Anderson said in an interview with MedTech Dive.
The results came from an analysis of insurance claims comparing people who used Persona IQ and Zimmer’s Mymobility platform with patients who did not receive those resources with their knee implant. Researchers at the Hospital for Special Surgery and Zimmer compared 1,081 patients with a smart implant to 4,324 in the control group.
At one year, they found revision rates were at 0.3% for the smart implant group versus 1% for the control group, and the rate of periprosthetic joint infection was 0.3% for the smart implants versus 0.9% for the control group.
Because the study is from claims data, it’s difficult to know what post-operative changes drove the result, Anderson said. Patients can send messages directly, and receive education and exercises through the Mymobility app, he said, while the Persona IQ data can show changes in their activity or mobility metrics.
“Unfortunately, we don’t know if the surgeons did anything with the objective data, but we do know that there were opportunities for surgeons to do that, and opportunities for patients to reach out and really self direct their rehabilitation,” Anderson said.
Zimmer received the Food and Drug Administration’s de novo authorization for its smart knee implant in 2021. The device tracks metrics including stride length, range of motion, step count and walking speed.
While the idea of implants with built-in sensors drew initial interest, there were also several big unanswered questions around how to use the data. For example, what trends should a clinician watch for as an early sign of a problem?
Anderson said that he has seen more publications delving into that issue. A presentation this week showed a decrease in a patient’s gait patterns two to three days before they were diagnosed with infection.
“It’s an exciting time to have data like this, because the data is starting to get popular, and we’re seeing these associations, but we don’t truly know the causality between the data and the complications,” Anderson said.
In the future, if Zimmer would like to offer alerts for interventions based on this data, he said prospective, randomized clinical trials will be needed to demonstrate that receiving an alert and acting on it reduces complications.
