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New treatment option for Amputation
Official title Powered Prosthesis for Use With TF Osseointegration Recipients
ClinicalTrials.gov ID: NCT06160882
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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
You likely can't join 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...
- Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or...
- Visually impaired
- Proximal nerve injury that prevents TMR
- Individuals who smoke: may interfere with OI process from both bone healing and soft tissue standpoints
See the full eligibility criteria
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.