Clinical trial NCT04063592: AMI Construction in Lower Extremity Residual Limbs
Official title: A Novel Approach to Lower Extremity Residual Limb Revision to Augment Volitional Motor Control, Restore Proprioception and Reverse Limb Atrophy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amputation
Keywords: Amputation
Residual limb pain
Phantom pain
Residual limb atrophy
Prosthesis control
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts Institute of Technology
name: Walter Reed National Military Medical Center
name: United States Department of Defense
First posted: 2019-08-21
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective clinical trial in which intervention subjects will serve as their own control
Primary purpose: TREATMENT

Brief 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: 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

Primary outcomes:
measure: Limb Morphology and Changes in Muscle Volume
timeFrame: Years 1-3
measure: Degree of Motor Activation of AMI Muscles and Volitional Control of Phantom Limb
timeFrame: Years 1-3
measure: Evidence of Proprioception
timeFrame: Years 1-3
measure: Evidence of Sensory Perception
timeFrame: Years 1-3
measure: General Health
timeFrame: Years 1-3
measure: Complications
timeFrame: Years 1-3
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Cambridge
country: United States
facility: Massachusetts Institute of Technology
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Matthew J Carty, MD
role: PRINCIPAL_INVESTIGATOR
References: