AMI Construction in Lower Extremity Residual Limbs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-24

Study Completion Date

2026-09-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Amputation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective clinical trial in which intervention subjects will serve as their own control

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Subjects undergoing the proposed operative intervention. Intervention patients will serve as their own control for all outcome measures

Group Type EXPERIMENTAL

Residual limb revision

Intervention Type PROCEDURE

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

Interventions

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Residual limb revision

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes