Status:
RECRUITING
Powered Prosthesis for Use With TF Osseointegration Recipients
Lead Sponsor:
Shirley Ryan AbilityLab
Collaborating Sponsors:
Northwestern University
Northwestern Memorial Hospital
Conditions:
Amputation
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate functional mobility, control, and user satisfaction from persons who have an amputation above the knee and have received osseo-integration (OI) and targeted mu...
Detailed Description
The objective of this study is to evaluate functional mobility, non-weight-bearing neural control, and user satisfaction from individuals with unilateral transfemoral amputation who have received osse...
Eligibility Criteria
Inclusion
- Unilateral lower limb amputation at the transfemoral level
- Existing prosthesis wearer
- K2/K3/K4 level ambulation
- 18-70 years old
- Mini-Mental State Exam (MMSE) score greater than 17
- Ability to demonstrate proper safety with passive prosthesis
- Candidate for a myoelectric prosthesis (can generate mV level electromyographic EMG signals as detected by surface electrodes
- Candidate for OI surgery as verified by surgical team or has previously received OI
- Candidate for TMR surgery as verified by surgical team or has previously received TMR
Exclusion
- Unable to successfully receive osseointegration and TMR
- Significant new injury that would prevent use of a prosthesis: Ability to consistently wear prosthesis and perform activities of daily living and specific performance tasks is necessary to properly evaluate the relative benefits of the intervention
- Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate useable, reliable data.
- Visually impaired
- Proximal nerve injury that prevents TMR
- Individuals who smoke: may interfere with OI process from both bone healing and soft tissue standpoints
- Individuals with active implants.
- Significant comorbidity that would preclude completion of the study, use of prostheses, or would otherwise prevent data acquisition by researchers
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06160882
Start Date
January 1 2024
End Date
October 1 2028
Last Update
March 18 2025
Active Locations (1)
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1
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611