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Clinical Trial NCT04063592 for Amputation is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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AMI Construction in Lower Extremity Residual Limbs 26 Novel Treatment

Recruiting
Clinical Trial NCT04063592 is an interventional study for Amputation that is recruiting. It started on February 24, 2020 with plans to enroll 26 participants. Led by Brigham and Women's Hospital, it is expected to complete by September 30, 2026. The latest data from ClinicalTrials.gov was last updated on October 20, 2025.
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 ...Show More
Official Title

A Novel Approach to Lower Extremity Residual Limb Revision to Augment Volitional Motor Control, Restore Proprioception and Reverse Limb Atrophy

Conditions
Amputation
Other Study IDs
  • 2019P001681
  • CDMRP-180114 (Other Grant/Funding Number) (Department of Defense)
NCT ID Number
NCT04063592
Start Date (Actual)
2020-02-24
Last Update Posted
2025-10-20
Completion Date (Estimated)
2026-09-30
Enrollment (Estimated)
26
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Amputation
Residual limb pain
Phantom pain
Residual limb atrophy
Prosthesis control
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalIntervention
Subjects undergoing the proposed operative intervention. Intervention patients will serve as their own control for all outcome measures
Residual limb revision
Surgical procedure involving construction of agonist-antagonist myoneural interfaces (AMIs)
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
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.
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.
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.
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.
Years 1-3
Complications
Delayed wound healing, infection, need for additional surgery, PE/DVT, death
Years 1-3
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes

  • 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

  • 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
Brigham and Women's Hospital logoBrigham and Women's Hospital398 active studies to explore
Study Responsible Party
Matthew Carty, Principal Investigator, Principal Investigator, Brigham and Women's Hospital
Study Central Contact
Contact: Matthew J Carty, MD, 6179834555, [email protected]
Contact: Research Coordinators, [email protected]
3 Study Locations in 1 Countries

Maryland

Walter Reed National Military Medical Center, Bethesda, Maryland, 20889, United States
Kyle Potter, MD, Contact, [email protected]
Not yet recruiting

Massachusetts

Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States
Matthew J Carty, MD, Contact, 617-983-4555, [email protected]
Recruiting
Massachusetts Institute of Technology, Cambridge, Massachusetts, 02139, United States
Hugh Herr, PhD, Contact, 617-314-3661, [email protected]
Recruiting