An interventional study of Residual limb revision in Amputation, sponsored by Brigham and Women's Hospital. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
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:
163 studies on the registry are indexed under Phantom Limb; 35 are open to participants now.
This study's planned enrollment of 26 is below the median of 30 across 125 interventional studies indexed under Phantom Limb.
Browse Phantom Limb studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
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Suffers from symptoms such as:
Exclusion Criteria:
Subjects undergoing the proposed operative intervention. Intervention patients will serve as their own control for all outcome measures
Procedure: Residual limb revision
Surgical procedure involving construction of agonist-antagonist myoneural interfaces (AMIs)
Limb 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
Plan to share: No — Individual participant data will not be available to other researchers
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