USA: Ottobock and Hanger join resources in clinical research
Landmark clinical trial of seniors with limb loss aims to increase access to advanced prosthetic technology
Hanger, Inc. and Ottobock today announced they have joined resources to conduct a landmark 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 new coverage policies, offering greater access to seniors with above-knee limb loss.
The Hanger Institute for Clinical Research and Education and Ottobock are partnering with Hanger Clinic prosthetists around the country to conduct this landmark 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, meaning people who can navigate low-level environmental barriers like stairs and curbs. Specific data points measured 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 will be enrolled in the study. Half the patients will be randomized into a group fit with an Ottobock MPK, an advanced prosthetic technology 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,” stated Dr. James Campbell, 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).