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 — PROCEDURE
    Surgical 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: Intervention
    Subjects 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

Locations (3)

FacilityCityStateZIPSite coordinators
Walter Reed National Military Medical CenterBethesdaMaryland20889
Kyle Potter, MD
Brigham and Women's HospitalBostonMassachusetts02115
Matthew J Carty, MD
617-983-4555
Massachusetts Institute of TechnologyCambridgeMassachusetts02139
Hugh Herr, PhD
617-314-3661

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