Assist-Knee: Energy-Harvesting Knee Prosthesis

Orthocare Innovations

Status: Completed

Conditions: Artificial Limbs; Transfemoral Amputation

Treatments: Device: Assist-Knee; Device: Habitual Prosthesis

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT04023045

7826-01

1R43HD097826 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this research is to validate the Assist-Knee design and function by collecting pilot data during the stand-to-sit-to-stand transition in transfemoral prosthesis users when using the Assist-Knee to harvest energy and return energy .

Enrollment: 3 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Unilateral transfemoral limb loss
• At least one year post-amputation and currently successfully using a prosthesis
• Uses modular endoskeletal prosthetic components
• Has bilateral normal range of motion
• Ability to perform the following activities:
• Walking ability or ability to take steps over 10 meters
• Upright standing stability
• Stand-to-sit stability (i.e. go from a standing position to a seated position independently)
• Sit-to-stand stability (i.e. rise from a seated position independently)
• Ability to communicate individual perceptions in the English language
• Ability to provide informed consent

Exclusion criteria

• Confounding injury or musculoskeletal problem
• Pregnancy
• Lower limb peripheral neuropathy
• Symptomatic cardiovascular disease or chronic obstructive pulmonary disease
• Not able to read and understand English
• Use of assistive devices for sit-to-stand and stand-to-sit (e.g. canes, walkers)

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Habitual Prosthesis

Active Comparator group

Description:

Participant's prescribed prosthesis

Treatment:

Device: Habitual Prosthesis

Assist-Knee

Experimental group

Description:

Experimental knee prosthesis

Treatment:

Device: Assist-Knee