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Trial record 3 of 7 for:    carty

AMI Construction in Lower Extremity Residual Limbs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04063592
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : May 3, 2021
Sponsor:
Collaborators:
Massachusetts Institute of Technology
Walter Reed National Military Medical Center
United States Department of Defense
Information provided by (Responsible Party):
Matthew Carty, Brigham and Women's Hospital

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

Condition or disease Intervention/treatment Phase
Amputation Procedure: Residual limb revision Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective clinical trial in which intervention subjects will serve as their own control
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Novel Approach to Lower Extremity Residual Limb Revision to Augment Volitional Motor Control, Restore Proprioception and Reverse Limb Atrophy
Actual Study Start Date : February 24, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Balance Problems

Arm Intervention/treatment
Experimental: Intervention
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)




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Complications [ Time Frame: Years 1-3 ]
    Delayed wound healing, infection, need for additional surgery, PE/DVT, death



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04063592


Contacts
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Contact: Matthew J Carty, MD 6179834555 mcarty@partners.org
Contact: Lori Berger 6179834522 lberger5@bwh.harvard.edu

Locations
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United States, Maryland
Walter Reed National Military Medical Center Not yet recruiting
Bethesda, Maryland, United States, 20889
Contact: Kyle Potter, MD       benjamin.k.potter.mil@mail.mil   
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Matthew J Carty, MD    617-983-4555    mcarty@partners.org   
Massachusetts Institute of Technology Recruiting
Cambridge, Massachusetts, United States, 02139
Contact: Hugh Herr, PhD    617-314-3661    hherr@media.mit.edu   
Sponsors and Collaborators
Brigham and Women's Hospital
Massachusetts Institute of Technology
Walter Reed National Military Medical Center
United States Department of Defense
Investigators
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Principal Investigator: Matthew J Carty, MD Brigham and Women's Hospital
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Responsible Party: Matthew Carty, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04063592    
Other Study ID Numbers: 2019P001681
CDMRP-180114 ( Other Grant/Funding Number: Department of Defense )
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matthew Carty, Brigham and Women's Hospital:
Amputation
Residual limb pain
Phantom pain
Residual limb atrophy
Prosthesis control