Functional assessment and satisfaction of transfemoral amputees with low mobility (FASTK2): A clinical trial of microprocessor-controlled vs. non-microprocessor-controlled knees

Background: The benefits of a microprocessor-controlled knee are well documented in transfemoral amputees who are unlimited community ambulators. There have been suggestions that transfemoral amputees with limited community ambulation will also benefit from a microprocessor-controlled knee. Current medical policy restricts microprocessor-controlled knees to unlimited community ambulators and, thereby, potentially limits function. This clinical trial was performed to determine if limited community ambulators would benefit from a microprocessor-controlled knee. Methods: 50 unilateral transfemoral amputees, mean age 69, were tested using their current non-microprocessor-controlled knee, fit with a microprocessor-controlled knee and allowed 10 weeks of acclimation before being tested, and then retested with their original mechanical knee after 4 weeks of re-acclimation. Patient function was assessed in the free-living environment using tri-axial accelerometers. Patient satisfaction and safety were also measured. Findings: The subjects demonstrated improved outcomes when using the microprocessor-controlled knee. Subjects had a significant reduction in falls, spent less time sitting, and increased their activity level. Subjects also reported significantly better ambulation, improved appearance, and greater utility. Interpretation: This clinical trial demonstrated that transfemoral amputees with limited mobility clearly benefit from a microprocessor-controlled knee. Notably, a reduction in falls occurred while the subjects engaged in more physical activity, which resulted in increased subject satisfaction. The increased activity resulted in a greater exposure to fall risk, but that risk was moderated by the advanced technology. ClinicalTrials.gov