1C70 Feasibility Study

Prospective, Feasibility Study to Evaluate Performance, Patient Benefits, and Acceptance of a New 1C70 Energy Storage and Return Prosthetic Foot

The objective of this study is to characterize the extent of 1C70 meeting the amputees needs in comparison with their everyday and a comparator foot, in regards of daily activities, mobility and balance, as well as quality of life and pain.

Inclusion Criteria:

• Person is at least 18 years old.
• Person is a unilateral transtibial amputee with stabilized residual limb.
• Person is a K3 ambulator based on Medicare Functional Classification Level (MFCL) .
• Person has at least 6 months experience in walking with a prosthesis.
• Person is using an energy storage and return (ESR) foot as their primary everyday foot
• Person has a foot size between 22 and 30.
• Person weights with a prosthesis between 50 and 125 kg (foot size 26 - 30), or between 45 and 100 kg (foot size 22 - 25).
• Person wears a prosthesis daily and ≥ 8 hours/day.
• Person is able to walk at least 500 m without having to make a break.
• Person is willing and able to independently provide informed consent.
• Person is willing to comply with study procedures.

Exclusion Criteria:

• Person is pregnant.
• Person is using a hydraulic foot as their primary everyday foot.
• Person is using a sport foot (e.g., Fillauer AllPro, Ottobock Challenger, Össur Flex-Foot Cheetah) as their primary everyday foot.
• Person is using an ESR foot with an integrated vacuum pump (e.g., Ottobock 1C62 Triton Harmony).
• Person has conditions that would prevent participation and pose increased risk (e.g., unstable cardiovascular conditions that preclude physical activity such as walking).
• Person falls ≥ once a week due to the reasons that are not related to prosthesis (e.g., problems with vestibular system).
• Person is not available for study visits during planned study duration.
• Person is participating in another study or intends to participate in another study during this study´s duration.
• Person cannot personally provide their consent.