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NCT04063592NARecruitingAccepts Healthy Volunteers

AMI Construction in Lower Extremity Residual Limbs

Brigham and Women's Hospital

Start Date

2/24/2020

Completion Date

9/30/2026

Summary

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

Detailed Description

The hypothesis of this research protocol is that we will be able to modify the residual limbs of patients who have already undergone lower extremity amputations so as to include biological actuators that will enable the successful employment of next generation lower extremity prostheses, diminish/eliminate phantom limb pain, restore proprioception and regenerate lost muscle mass. The specific aims of the project are as follows: 1. To develop a standardized operative technique for both above knee (AK) and below knee (BK) amputation revision procedures that includes AMIs to restore musculotendinous proprioceptive capabilities 2. To assess the capacity for these actuators to provide enhanced motor control and sensory feedback, as well as ablate phantom limb symptomatology and augment residual limb muscle mass 3. To determine the reinnervation time course and longevity of these biological constructs 4. To validate the functional and somatosensory superiority of the proposed revision technique over standard approaches to BKA and AKA 5. To develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach

Eligibility Criteria

Age Range: 18 years to 65 years

Inclusion Criteria: * Between the ages of 18-65 * Has already undergone a standard AKA or BKA procedure * Suffers from symptoms such as: * Intractable pain * Deterioration of skin on or around stump * Suffering from other sources of discomfort arising from stump * Intact inherent wound healing * Adequate communication skills * High motivation Exclusion Criteria: * Inadequate health to undergo operative procedure using standard anesthesia (i.e. cardiopulmonary) * Individuals with impaired wound healing * Individuals suffering from extensive peripheral neuropathies * Active smokers * Individuals with a history of poor compliance * Women who are pregnant or plan to become pregnant before surgical intervention

Interventions

PROCEDURE

Residual limb revision

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Conditions

Amputation

Locations

Walter Reed National Military Medical Center

Bethesda, Maryland 20889

United States

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States

Massachusetts Institute of Technology

Cambridge, Massachusetts 02139

United States