AMI Construction in Lower Extremity Residual Limbs
Purpose
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
Condition
- Amputation
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Prospective clinical trial in which intervention subjects will serve as their own control
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention |
Subjects undergoing the proposed operative intervention. Intervention patients will serve as their own control for all outcome measures |
|
Recruiting Locations
Boston, Massachusetts 02115
More Details
- Status
- Recruiting
- Sponsor
- Brigham and Women's Hospital
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