Implants with sensors, computational power, and the ability to communicate via the internet, otherwise known as “smart” implants are moving into the operating room and patient’s knees. What effect might these smart implants have on patient outcomes?
Hanger, Inc. and Ottobock have just announced a 5-year collaboration to answer that question by way of a clinical study to collect health benefit data that microprocessor-controlled knee technologies might provide to patients over the age of 65.
The Hanger Institute for Clinical Research and Education and Ottobock are partnering with Hanger prosthetists around the U.S. on this prospective randomized trial. Known by the name, ASCENT K2 (ASsessing outComes with microprocEssor kNee uTilization K2), the study will measure the short- and long-term effects of a microprocessor-controlled knee in K2-level community ambulators (individuals who have the capacity to navigate low-level environmental barriers like stairs and curbs). The team will examine health-related quality of life, participation in society and activities, fall rates, and participants’ fear of falling.
The study enrollment is underway and plans are in place to enroll 100 Hanger Clinic patients by the end of March 2022. One half of the patients will be fitted for an Ottobock MPK (microprocessor-controlled knee), described by the company as “an advanced prosthetic technology typically only covered for higher-level K3 or K4 ambulators.” Those in the other half will be the control group and will only be using mechanical, non-microprocessor-controlled knee knees. The first analyses will be published at one-year, and then annually for five years.
“We are delighted to leverage our collaborative research capabilities and clinical expertise to gather much-needed data about the growing population of seniors with lower limb amputations,” stated James Campbell, Ph.D., chief clinical officer of the Hanger Institute for Clinical Research and Education. “This important research is designed to help ensure people living with limb loss have coverage for medically necessary and clinically appropriate technology, which will, in turn, enable them to participate more fully in their communities and enjoy a higher quality of life.”
“Ottobock has been working on the generation of scientific evidence for the benefits of MPK in K2 patients for 15 years now with several clinical studies conducted at academic research centers with only limited access to this patient population. We are very pleased that our partnership with Hanger Clinic enables our two companies now to run the biggest interventional study yet in the real-life environment of prosthetic clinics that should eventually compel the healthcare payer community of the benefits that MPK deliver to limited community ambulators,” said Dr. Andreas Hahn, VP Clinical Research & Services, Otto Bock Healthcare Products GmbH, Vienna (Austria).
Increased Stability
“Microprocessor-controlled knee technologies have been around for more than two decades and are among the most studied components in prosthetic rehabilitation,” said Dr. Campbell to OTW. “Over that period of time there has become increased awareness of the potential benefits of a prosthetic knee that senses the person’s movement and responds in real time. A microprocessor-controlled knee allows transfemoral amputees to walk with a more stable and efficient gait, most notably, there is a reduction in falls, and injurious falls, for individuals using a microprocessor-controlled knee.”
“Importantly, microprocessor-controlled knees are only generally accessible to unlimited community ambulators, defined as an individual who has the ability to traverse most environmental barriers and can walk at different speeds. For the limited community ambulator, typically represented by older individuals, access to this level of care and appropriate prosthetic technology can be a challenge. This is concerning as a fall in this group of individuals, that may have been prevented by the added stability afforded by a microprocessor-controlled knee, can have serious consequences.”
When OTW inquired as to how they will assess the fear of falling, Dr. Campbell stated, “We have multiple endpoint measures throughout the duration of the clinical trial. These include measures that inform the degree to which fear of falling is interfering with daily life through a fear of falling activity avoidance outcome measure to the number of falls and near-falls that patients experience. We are also assessing changes in activity profile and health related quality of life.”
