First results concerning the safety, walking, and satisfaction with an innovative, microprocessor-controlled four-axes prosthetic foot.

BACKGROUND: The microprocessor-controlled foot Meridium is a prosthetic component with adjustable stance-phase characteristics. OBJECTIVES: To investigate subjects' and prosthetists' perception of safety, walking, and satisfaction during first routine fittings. STUDY DESIGN: Multicenter, prospective, observational cohort study. METHODS: Data regarding demographics, fitting process, safety, daily life activities, and satisfaction were obtained through questionnaires. The follow-up period was 7 months. RESULTS: In all, 89% of 70 users were satisfactorily fitted within the first two visits. Compared to previous feet, users reported improvements in walking on level ground (54% of subjects), uneven ground (82%), ascending (97%), and descending ramps (91%). More than 45% of the users perceived an improvement in safety and stability while standing and walking. No difference was observed in concentration, exertion, and pain. Overall user satisfaction with Meridium was 50% and the foot was preferred by 40% of users. Amputation level, age and mobility grade did not influence subjects' preference. Prosthetists recommended Meridium for 59% of subjects. A correlation analysis revealed that transfemoral amputees fitted with Genium and/or having a long residual limb strongly preferred Meridium ( p < 0.05). CONCLUSION: Meridium was appreciated by amputees with a preference for natural walking and requirement to safely and comfortably negotiate uneven terrain and slopes. Clinical relevance Amputees preferring Meridium perceive benefits with safe, comfortable, and natural walking. While the perception of benefits regarding the negotiation of uneven terrain and slopes is very high, the correlation to product preference is moderate. Individual assessment and trial fitting might be essential to identify patients who benefit greatly.