Menu
Recruiting NCT04063592

AMI Construction in Lower Extremity Residual Limbs

No phase Interventional Amputation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Residual limb revision.
Who it may be relevant to
Registry conditions: Amputation. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Procedure Residual limb revision
    Surgical procedure involving construction of agonist-antagonist myoneural interfaces (AMIs)

Primary outcome measures

  • Limb Morphology and Changes in Muscle Volume [Time frame: Years 1-3]
  • Degree of Motor Activation of AMI Muscles and Volitional Control of Phantom Limb [Time frame: Years 1-3]
  • Evidence of Proprioception [Time frame: Years 1-3]
  • Evidence of Sensory Perception [Time frame: Years 1-3]
  • General Health [Time frame: Years 1-3]
  • Complications [Time frame: Years 1-3]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Walter Reed National Military Medical Center — Bethesda
  • Brigham and Women's Hospital — Boston
  • Massachusetts Institute of Technology — Cambridge

Identifiers

NCT: NCT04063592 · 2019P001681 · CDMRP-180114

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗