1C70 Feasibility Study

Otto Bock Healthcare (Ottobock)

Status: Completed

Conditions: Amputation

Treatments: Device: Pro-Flex XC; Device: 1C70

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05628064

CIV-22-08-040306 (Other Identifier)

D000002112

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

1C70 to Pro-Flex XC

Experimental group

Description:

Transtibial amputees randomized to start with 1C70 and cross over to Pro-Flex XC

Treatment:

Device: Pro-Flex XC

Device: 1C70

Pro-Flex XC to 1C70

Experimental group

Description:

Transtibial amputees randomized to start with Pro-Flex XC and cross over to 1C70

Treatment:

Device: Pro-Flex XC

Device: 1C70