NCT06160882 Powered Prosthesis for Use With TF Osseointegration Recipients
| NCT ID | NCT06160882 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shirley Ryan AbilityLab |
| Condition | Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 6 participants in total. It began in 2024-01-01 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 muscle reinnervation (TMR) surgery, while walking with a powered knee and ankle prosthesis.
Eligibility Criteria
Inclusion 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 Exclusion Criteria: * 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
Contact & Investigator
Levi Hargrove, PhD
PRINCIPAL INVESTIGATOR
Shirley Ryan AbilityLab
Frequently Asked Questions
Who can join the NCT06160882 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06160882 currently recruiting?
Yes, NCT06160882 is actively recruiting participants. Contact the research team at sfinucane@sralab.org for enrollment information.
Where is the NCT06160882 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06160882 clinical trial?
NCT06160882 is sponsored by Shirley Ryan AbilityLab. The principal investigator is Levi Hargrove, PhD at Shirley Ryan AbilityLab. The trial plans to enroll 6 participants.