AMI Construction in Lower Extremity Residual Limbs
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 20
Summary
- Conditions
- Amputation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Prospective clinical trial in which intervention subjects will serve as their own controlMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
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/el...
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: 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 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 To determine the reinnervation time course and longevity of these biological constructs To validate the functional and somatosensory superiority of the proposed revision technique over standard approaches to BKA and AKA To develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach
Tracking Information
- NCT #
- NCT04063592
- Collaborators
- Massachusetts Institute of Technology
- Walter Reed National Military Medical Center
- United States Department of Defense
- Investigators
- Principal Investigator: Matthew J Carty, MD Brigham and Women's Hospital