A Novel Approach to Lower Extremity Residual Limb Revision to Augment Volitional Motor Control, Restore Proprioception and Reverse Limb Atrophy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Amputation
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 26
- Locations
- 3
- Primary Endpoint
- Evidence of Sensory Perception
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
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
Investigators
Matthew Carty
Principal Investigator
Brigham and Women's Hospital
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
Outcomes
Primary Outcomes
Evidence of Sensory Perception
Time Frame: Years 1-3
Subjective reporting and clinical tests of Semmes-Weinstein and two-point discrimination will determine if the patient has sensory perception on the residual limb.
Limb Morphology and Changes in Muscle Volume
Time Frame: Years 1-3
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.
Evidence of Proprioception
Time Frame: Years 1-3
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.
General Health
Time Frame: Years 1-3
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.
Degree of Motor Activation of AMI Muscles and Volitional Control of Phantom Limb
Time Frame: Years 1-3
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.
Complications
Time Frame: Years 1-3
Delayed wound healing, infection, need for additional surgery, PE/DVT, death