AMI Construction in Lower Extremity Residual Limbs
Part of paid clinical trials in Bethesda, Maryland.
- Sponsor
- Brigham and Women's Hospital
- Study ID
- NCT04063592
- Status
- Recruiting
Conditions
- Amputation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- Residual limb revision — PROCEDURESurgical procedure involving construction of agonist-antagonist myoneural interfaces (AMIs)
Study Details
This study will involve the development of a novel approach to lower extremity residual limb surgical revision that offers the promise of augmenting volitional motor control, restore proprioception and reverse atrophy
Key Dates
- Start date
- Feb 24, 2020
- Status verified
- Oct 2025
- Primary completion
- Sep 30, 2026
- Completion
- Sep 30, 2026
Study Design
- Enrollment
- 26 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: InterventionSubjects undergoing the proposed operative intervention. Intervention patients will serve as their own control for all outcome measures
Primary Outcome Measure
Limb Morphology and Changes in Muscle Volume [ Time Frame: Years 1-3 ]
Central Contacts
- Matthew J Carty, MD6179834555
- Research Coordinators
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | Kyle Potter, MD |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | |
| Massachusetts Institute of Technology | Cambridge | Massachusetts | 02139 |
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