Hanger, Austin, Texas, and Ottobock, Duderstadt, Germany, have joined resources to conduct a five-year clinical study to collect data around what potential health benefits microprocessor-controlled knee (MPK) technologies provide people 65 and older. This endeavor would establish evidence that could expand and support coverage policies.
The Hanger Institute for Clinical Research and Education and Ottobock are partnering with Hanger Clinic prosthetists nationwide to conduct the prospective randomized trial. ASCENT K2 (Assessing outcomes with microprocessor knee utilization in a K2 population) will measure the short-and long-term effects of MPK use in K2-level community ambulators. Data points will include health-related quality of life, participation in society and activities, fall rates, and participants’ fear of falling.
ASCENT K2 began enrolling test subjects and fit its first MPK recipient in July. By the end of March 2022, 100 Hanger Clinic patients are expected to be enrolled in the study. Half of the patients will be randomized into a group fit with an Ottobock MPK, typically only covered for higher-level K3 or K4 ambulators. The other half will form a control group using mechanical, non-MPK knees, the current standard for K2 ambulators. Participants will be assessed periodically throughout their first 12 months in the study, with initial analyses published at the one-year mark, 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,” said James Campbell, PhD, chief clinical officer of the Hanger Institute for Clinical Research and Education. “This 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 with several clinical studies conducted at academic research centers with only limited access to this patient population. We are 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 Andreas Hahn, PhD, VP clinical research and services, Otto Bock Healthcare Products, Vienna, Austria.
