Powered Prosthesis for Use With TF Osseointegration Recipients

Recruiting now · Not applicable

Conditions studied: Amputation

In brief

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 muscle reinnervation (TMR) surgery, while walking with a powered knee and ankle prosthesis.

Key facts

Study ID

NCT06160882

Run by

Shirley Ryan AbilityLab

People needed

6

Starts

2024-01-01

Expected to finish

2028-10-01

Last updated by the study team

2025-03-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Shirley Ryan AbilityLab — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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