Kenton R Kaufman1, Kathie A Bernhardt2, Kevin Symms3. 1. Motion Analysis Laboratory, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. Electronic address: kaufman.kenton@mayo.edu. 2. Motion Analysis Laboratory, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. 3. Hanger Clinic, 10910 Domain Drive, Suite 300, Austin, TX 78758, USA.
Abstract
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 No: NCT02240186.
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 No: NCT02240186.
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