AMI Construction in Lower Extremity Residual Limbs

Last updated: October 15, 2025
Sponsor: Brigham and Women's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Residual limb revision

Clinical Study ID

NCT04063592
2019P001681
CDMRP-180114
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 26
Treatment Group(s): 1
Primary Treatment: Residual limb revision
Phase:
Study Start date:
February 24, 2020
Estimated Completion Date:
September 30, 2026

Study 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

Connect with a study center

  • Walter Reed National Military Medical Center

    Bethesda, Maryland 20889
    United States

    Site Not Available

  • Walter Reed National Military Medical Center

    Bethesda 4348599, Maryland 4361885 20889
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts Institute of Technology

    Cambridge, Massachusetts 02139
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Active - Recruiting

  • Massachusetts Institute of Technology

    Cambridge 4931972, Massachusetts 6254926 02139
    United States

    Active - Recruiting

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