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
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Surgical procedure involving construction of agonist-antagonist myoneural interfaces (AMIs)
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
NOT_YET_RECRUITINGBrigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGMassachusetts Institute of Technology
Cambridge, Massachusetts, United States
RECRUITINGLimb Morphology and Changes in Muscle Volume
Clinical examination and images from CT/MRI will be combined to construct a holistic view of the morphology of the residual limb. Imaging studies and limb measurements taken in clinic will also be used to measure muscle atrophy/hypertrophy over time.
Time frame: Years 1-3
Degree of Motor Activation of AMI Muscles and Volitional Control of Phantom Limb
Clinical examination will confirm the sliding motion of the AMI constructs with radiologic evaluation measuring the length of muscle excursion through each construct. Functional testing and testing using a prosthesis will determine how well a patient is able to volitionally control the AMI muscles.
Time frame: Years 1-3
Evidence of Proprioception
Subjective reporting combined with tests run using a prosthesis will indicate if proprioception is still intact after surgery. Results will be confirmed by monitoring brain activity during limb movement activities via fMRI.
Time frame: Years 1-3
Evidence of Sensory Perception
Subjective reporting and clinical tests of Semmes-Weinstein and two-point discrimination will determine if the patient has sensory perception on the residual limb.
Time frame: Years 1-3
General Health
Patient-reported outcomes metrics from five validated tests (SIP136, EQ-5D, SF-36, LEFS, PROMIS) will be combined to create an overall picture of patients' general health during and after their recovery.
Time frame: Years 1-3
Complications
Delayed wound healing, infection, need for additional surgery, PE/DVT, death
Time frame: Years 1-3
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