Assist-Knee: Energy-Harvesting Knee Prosthesis

NCT04023045 | Completed Results FDA Device

• 2 other identifiers: 7826-011R43HD097826
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Transfemoral Amputation; Artificial Limbs

Outcome Measures

Primary Outcomes (2)

• Time to Complete Sit-to-Stand

  The amount of time, measured in seconds, needed by the subject to complete the sit-to-stand transition. At least four trials of the sit-to-stand maneuver were collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the sit-to-stand transition were calculated for each participant (each participant served as their own control in this pilot study). The start of the transition was determined by participant initiation; the end of the transition was determined by the participant reaching full knee extension.

  Collection at baseline

• Time to Complete Sit-to-Stand

  The amount of time, measured in seconds, needed by the subject to complete the sit-to-stand transition. At least four trials of the sit-to-stand maneuver were collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the sit-to-stand transition were calculated for each participant (each participant served as their own control in this pilot study). The start of the transition was determined by participant initiation; the end of the transition was determined by the participant reaching full knee extension.

  After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)

Secondary Outcomes (6)

• Timed Up and Go (TUG) Test

  Collection at baseline

• Timed Up and Go (TUG) Test

  After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)

• Time to Complete Stand-to-Sit

  Collection at baseline

• Time to Complete Stand-to-Sit

  After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)

• Percentage of Body Weight on Contralateral Limb at 65 Degrees Knee Flexion

  Collection at baseline

Study Arms (2)

Habitual Prosthesis

ACTIVE COMPARATOR

Participant's prescribed prosthesis

Device: Habitual Prosthesis

Assist-Knee

EXPERIMENTAL

Experimental knee prosthesis

Device: Assist-Knee

Interventions

Assist-Knee DEVICE

Assist-Knee is an experimental lower limb knee prosthesis.

Assist-Knee

Habitual Prosthesis DEVICE

Habitual baseline prosthesis prescribed by participant's clinician.

Habitual Prosthesis

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Orthocare Innovations, LLC: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Orthocare Innovations, LLC

Edmonds, Washington, 98020, United States

Location

Limitations and Caveats

This clinical trial collected data with a small number of participants. These results may not be generalizable to the entire population. Furthermore, this clinical trial used the Assist-Knee experimental prototype which is in a proof-of-concept stage. There is a potential for the outcome measures to improve as the Assist-Knee device design is refined through development.

Results Point of Contact

• Title: Sarah Chang
• Organization: Orthocare Innovations, LLC

schang@orthocareinnovations.com

425-771-0797

Study Officials

• Sarah Chang, PhD

  Orthocare Innovations, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Crossover clinical trial

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 17, 2019
• Study Start: July 15, 2019
• Primary Completion: February 26, 2020
• Study Completion: February 26, 2020
• Last Updated: October 18, 2023
• Results First Posted: October 7, 2022

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)