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Data analytics improves the performance of online marketers, baseball managers and political strategists. Why shouldn’t surgeons and their patients benefit from deep dives into clinical outcomes that indicate how well (or not well) joint replacements are performed or what went right (or not right) during entire episodes of care?
The data collected before, during and after surgeries can be used to develop algorithms for predictive analytics and planning, and create surgical roadmaps for future operations that are much more accurate — and potentially more effective — than current standards.
“We’ve been looking at the full continuum of care to determine what aspects can be improved upon,” said Liane Teplitsky, President of Global Robotics, Technology and Data Solutions at Zimmer Biomet. “Basing process improvements on objective measures of data will be key.”
Platforms that quantify the continuum of care by digitizing current practices will lead to positive change, according to Teplitsky. The implications of continuous monitoring and data aggregation allow for real-time interventions and therapies that enhance outcomes and help physicians better understand a patient’s individual course of recovery.
Forecasting Positive Outcomes
Exactech offers a unique tool called Predict Plus, a true machine learning-based outcome predictor. Its concept was born in 2004 as the company planned to launch the Equinox shoulder system. Surgeons involved in developing the system came from an academic background, and wanted to publish the results of the device’s clinical trial.
“We established a multi-center study, which has grown over the years as new devices have come to market,” said Chris Roche, Senior Vice President of Extremities at Exactech. “More than 16,000 patients are now included.”
Exactech has used the research to create algorithms based on more than 300 unique preoperative data points about the care of patients and uses the information to predict postoperative outcomes at various intervals.
“We identified 20 parameters that are about 90% accurate in predicting how shoulder arthroplasty patients will respond to surgery in terms of the joint’s range of motion, pain levels and overall satisfaction scores from as early as three months after surgery to about seven years post-op,” Roche said.
The current version of Predict Plus is free to use as a standalone software program. Exactech plans to integrate the program into the company’s CT-based planning software to convert it into a true clinical decision and support tool.
“We’re trying to create and capture integrated data that flows into the algorithms,” Roche said. “Surgeons have said the information helps them more accurately communicate the potential risks and benefits of surgery to patients during the informed consent process.”
Most smart implants on the market today have a diagnostic component, but not much is being done to use the data that’s received to alter a patient’s course of care. That could be an issue from a business perspective, according to Benjamin Hertzog, Ph.D., CEO of Intelligent Implants. “The complexity of a device that collects data makes it more expensive, and it’s difficult to justify the added cost if the data doesn’t provide clinical value,” he said.
Intelligent Implants’ digital solutions are addressing the value-added issue by incorporating a therapeutic component into a smart scaffold for spine surgery, while at the same time using the device to collect data that can be mined for predictive analytics. In the future, the data could help physicians match appropriate therapies to individual patients and adjust the treatments based on how the patients respond.
“Providers can use meaningful data to monitor how well patients are healing from surgery and adjust their care in real time,” Dr. Hertzog said. “But a longer-term benefit is in play. If we’re able to collect and mine data on every patient within the healthcare system, we’ll start to see different healing curves develop, and we’ll start to identify the needs of various patient populations.”
High-tech Help for Healing
After most orthopedic surgeries, patients undergo physical therapy and take pain medications to help them recover in relative comfort. Surgeons assess the effectiveness of surgery and the status of their recoveries during post-op evaluations.
It’s an imperfect process. Patients can skip physical therapy sessions, forget to take doses of prescribed medications or provide surgeons with an incomplete or inaccurate picture of their health status during post-op follow-up visits.
None of the elements are quantifiable, and orthopedic companies seek to address this issue by enabling digital interaction and data collection for a more objective look at the recovery process.
“Technology is more likely to be used if it removes the burden of compliance,” Teplitsky said. “We’ve looked at our platforms to see what we can automate and what processes can be made easier for patients and providers.”
Zimmer Biomet’s ZB Edge suite integrates digital and robotic technologies across the continuum of care. It includes the mymobility platform, which sends pre- and postoperative information directly to patients’ personal Apple devices. The company has launched recovery curves with the platform as well, so patients and physicians can better understand the progress of recoveries relative to other patients in the same peer group.
Canary Medical partnered with Zimmer Biomet to develop the Persona IQ, a smart knee implant that collects gait metrics in conjunction with the Canary Tibial Extension (CTE) and Canary Health Implanted Reporting Processor (CHIRP) System.
The smart implant collects real-time data on patients’ mobility, aggregates and analyzes it, and sends the information to a cloud-based platform, where surgeons can monitor the recovery progress.
“We employed the same transmission technology used in pacemakers,” said Bill Hunter, M.D., CEO of Canary Medical. “The goal was to collect data directly from the surgical site and provide the feedback to clinicians.”
The company hollowed out the stem of the Persona IQ implant’s tibial component and added a battery, a transmitter and sensors to collect and transmit data. The batteries are strong enough and have a low enough power draw to collect data for about 20 years.
Canary Medical’s solution can help individual patients heal properly. It also has the potential to study the long-term impact of surgery and inform future procedures.
“We won’t be solely analyzing data of acute recoveries over weeks or months,” Dr. Hunter said. “We have the potential to look at the entire patient journey over protracted periods of time.”
Grading on the Curve
Canary Medical recently launched Canary Quantile Recovery Curves, an analytic module that collects data from all patients who received the Persona IQ implant. Data pooled from multiple patients allows surgeons to compare the parameters of individual patients — activity levels and knee kinematics — and rank them against peers of the same gender, who are in the same age group and who have a similar elapsed time since they underwent surgery. Surgeons can use that comparison to guide the recovery plan of individual patients in the year following surgery.
The module is the only available monitoring tool that characterizes the recovery of knee replacement patients against aggregate population data collected from individuals with identical implants.
Data-based healing curves like the ones Canary Medical and Zimmer Biomet created could lead to the development of therapeutic regimens that better address the specific clinical needs of individual patients. Physicians would be able to identify heterogeneity among groups of patients and monitor how they heal in real time.
Orthopedics is at an infancy stage when it comes to developing and launching technologies that harness data. Forward-looking device companies and medtech firms believe in the benefits that these tools can offer surgeons and patients.
“Even patients who are healing well on their own by today’s standards could receive improved care,” Dr. Hertzog said. “Perhaps those patients could return to normal activities more quickly and get back their quality of life sooner. That represents huge value to patients. Mining data to extract that value is a big play.”
