RecruitingNot ApplicableNCT04063592

AMI Construction in Lower Extremity Residual Limbs

A Novel Approach to Lower Extremity Residual Limb Revision to Augment Volitional Motor Control, Restore Proprioception and Reverse Limb Atrophy


Sponsor

Brigham and Women's Hospital

Enrollment

26 participants

Start Date

Feb 24, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria9

  • 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 Criteria6

  • 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

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Interventions

PROCEDUREResidual limb revision

Surgical procedure involving construction of agonist-antagonist myoneural interfaces (AMIs)


Locations(3)

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Massachusetts Institute of Technology

Cambridge, Massachusetts, United States

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NCT04063592


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