System May Improve Lower-limb Prosthesis Fitting

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British-Portuguese biomedical company Adapttech released early data from its ongoing North American outcome study on a new system designed to make it faster and easier to correctly fit lower-limb prostheses and monitor a patient's rehabilitation process. Initial results show universal improvement in patient satisfaction scores and an improvement in functional status scores for some participants.

Socket fit is vital to the proper fit and function of all lower-limb prostheses. But the traditional fitting process uses a time-consuming trial-and-error methodology, with patients expected to give feedback on the socket's fitting through static and dynamic tests. The trial-and-error cycle can take up many hours of clinical time and multiple visits to achieve a proper fit, which can cause patient discomfort, loss of mobility, inconvenience, and other physical and psychological effects.

The system being tested, called INSIGHT, combines laser scanning, wearable technology, and a mobile app to provide prosthetists with biodata gathered by sensors in the socket to help detect problematic areas before a patient notices an issue.

The system is undergoing a 20-patient outcome study at De La Torre Orthotics and Prosthetics, Pittsburgh, and Prosthetics & Orthotic Associates (POA), Middletown, New York.

Early data from the first five patients to go through the fitting process at the De La Torre clinic showed that all five showed improved patient satisfaction scores based on McGann Client Feedback responses. Two of the five also saw an improvement in their Amputee Mobility Predictor with Prosthesis scores, moving from Medicare Functional Classification Level K3 to K4.

"The early results we are seeing from the INSIGHT fittings are encouraging," said Paul De La Torre, CPO and chairman, De La Torre Orthotics and Prosthetics. "We all want to provide a better patient experience, but if we can also improve their Amputee Mobility Predictor with Prosthesis (AMPPRO) scores, then this opens up new opportunities for patients to gain access to more advanced prostheses."

One of the patients involved in the study at De La Torre has a left transtibial amputation who has been using a prosthesis for 25 years.

"I was very impressed with the INSIGHT System as I was able to see where the pressure was in my socket when I was standing still and moving—and how the pressure changed as I moved," said the patient. "It reassured me to see the socket fitting properly and reducing pressure in all the right places at every stage of the testing."

"After using INSIGHT with the patient, I was more confident in the fit of the socket and what we were trying to accomplish, in terms of equal pressure distribution where it was needed along with reduced pressure in areas with more defined bony structure," said Drew Buffat, CP, De La Torre's director of prosthetics, who oversees the patients' fitting using INSIGHT. "The INSIGHT System is a good diagnostic tool that can help identify trouble spots in a socket since there are times when what a patient is telling us does not reflect the actual reality of what is occurring in the socket."

A patient participating in the fitting process at POA also has a left transtibial amputation and has been wearing a prosthesis for 24 years.

"In all these years, I've never been able to see what's going on with my leg," he said. "It's great because you can see what I feel. I can actually see why my leg was turning red."

"By showing the patient the areas of high pressure and the corresponding redness on his limb and sock ply fit, he was able to clearly see the impact of adding a sock," said Cassandra Delgado, CPO, MSPO, assistant director of clinical services at POA. "His success is going to be much greater now that he has seen a precise visual of his limb and how his decisions impact his health."

The outcome study continues at both clinics and is scheduled to be completed this spring.

Adapttech is headquartered in Birmingham, United Kingdom, with research and development in Porto, Portugal. Its US office is in Greenville, North Carolina.