Existing research suggests that K2-level community ambulators can benefit from using a microprocessor-controlled knee (MPK) and appropriate foot for their ambulation. The K2 population is usually prescribed a non-MPK, and often cannot obtain an MPK due to insurance policy restrictions. A recent study found that K2 individuals using an MPK along with an appropriate foot experienced better safety and performance capabilities.
The inference and evidence from the study adds to the knowledge base related to reimbursement policymaking for MPK prescription.
The goal of the 13-month clinical trial was to determine the benefits of using Ottobock’s C-Leg and 1M10 foot in people with unilateral transfemoral amputations due to vascular disease and who were classified at a K2 Medicare functional classification level (MCFL).
Ten individuals (mean age: 63 ± 9 years) participated, and baseline outcomes were collected with each participant’s current prosthesis. Participants were then randomized to one of two groups: an intervention with the MPK with a standardized 1M10 foot, or their predicate non-MPK with a standardized 1M10 foot.
On completion of the first intervention, participants crossed over to the next group to complete the study. Each intervention lasted for six months (three months of acclimation and three months of take-home trial to monitor home use). At the end of each intervention, clinical outcomes and self-reported outcomes were collected to compare with the baseline performance, and the researchers compared the performance of each intervention with respect to each participant’s own baseline.
Statistically significant and clinically meaningful improvements were observed in the participants’ gait performance, safety, and self-reported measures when using the MPK C-Leg plus 1M10 foot, according to the study’s authors. Most participants were able to achieve higher clinical scores in gait speed, balance, self-reported mobility, and fall safety, while using the MPK plus 1M10 combination. The improvement in scores were within range of scores achieved by individuals with K3 functional level as reported in previous studies.
The open-access study, “Using a microprocessor knee (C-Leg) with appropriate foot transitioned individuals with dysvascular transfemoral amputations to higher performance levels: a longitudinal randomized clinical trial,” was published in the Journal of NeuroEngineering and Rehabilitation.