Hanger, Inc. and Ottobock announced a critical enrollment milestone has been reached in the ASCENT K2 (ASsessing outComes with microprocEssor kNee uTilization in a K2 population) clinical trial. The study began enrolling patients in July 2021, and has now closed enrollment, having met the target enrollment of 100 K2-level community ambulators. The landmark 5-year clinical trial is collecting data that measures potential health benefits when microprocessor-controlled knees (MPK) are integrated into the care pathway for patients 65 and older. The enrollment milestone is double the size of any previous interventional trial assessing MPK use in K2 ambulators. The findings from this trial are designed to support new coverage policies, potentially providing expanded access to seniors with transfemoral limb loss.
The Hanger Institute for Clinical Research and Education and Ottobock have partnered with Hanger Clinic prosthetists from across the country to accomplish this prospective randomized trial. As part of the study, half of the participants have been randomly assigned to have an Ottobock MPK integrated into their prosthesis. Specific data points being measured include health-related quality of life, participation in society and activities, fall rates, and participants’ fear of falling. Participants will be assessed at various points throughout the clinical trial, with the initial primary analysis occurring once all subjects have completed the 12-month follow-up assessment. Longer-term follow-up will occur every 12 months for the duration of 5 years.
