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A Novel Approach to Upper Extremity Amputation to Augment Volitional Control and Restore Proprioception

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: NCT03882073
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : March 15, 2022
Sponsor:
Collaborators:
Massachusetts Institute of Technology
Walter Reed Army Institute of Research (WRAIR)
Information provided by (Responsible Party):
Matthew Carty, Brigham and Women's Hospital

Brief Summary:

The hypothesis of this research protocol is that the investigators will be able to redesign the manner in which upper limb amputations are performed so as to enable volitional control of next generation prosthetic devices and restore sensation and proprioception to the amputated limb. The investigators will test this hypothesis by performing modified above elbow or below elbow amputations in ten intervention patients, and compare their outcomes to ten control patients who have undergone tradition amputations at similar levels. The specific aims of the project are:

  1. To define a standardized approach to the performance of a novel operative procedure for both below elbow (BEA) and above elbow amputations (AEA)
  2. To measure the degree of volitional motor activation and excursion achievable in the residual limb constructs, and to determine the optimal configuration and design of such constructs
  3. To describe the extent of proprioceptive feedback achievable through the employment of these modified surgical techniques
  4. To validate the functional and somatosensory superiority of the proposed amputation technique over standard approaches to BEA and AEA
  5. To develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach

This will be a phase I/pilot clinical trial to be performed over a three-year period as a collaborative initiative involving Brigham & Women's Hospital/Brigham & Women's Faulkner Hospital (BWH/BWFH), Walter Reed National Military Medical Center (WRNMMC), and the Massachusetts Institute of Technology (MIT). The investigators will plan to perform 6 of the 10 amputations at BWH/BWFH, and 4 of the amputations at WRNMMC.


Condition or disease Intervention/treatment Phase
Amputation Procedure: Modified amputation procedure Procedure: Standard amputation procedure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Novel Approach to Upper Extremity Amputation to Augment Volitional Control and Restore Proprioception
Actual Study Start Date : May 1, 2019
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 group
Modified amputation procedure
Procedure: Modified amputation procedure
A fishmouth incision will be made. Radial and ulnar (BEA) or humoral (AEA) osteotomies will be performed. Segments of the flexor carpi radialis (FCR), extensor carpi radialis longus (ECRL), flexor digitorum profundi (FDP), extensor digitorum communis (EDC), flexor pollicis longus (FPL) and extensor pollicis longus (EPL) will be isolated, as well as the biceps (B) and triceps (T) groups in the AEA model; if it is not possible to preserve native innervation to these muscles, functional motor units will be constructed from muscle coapted to the appropriate motor nerve endings. Sensory nerve endings of the distal median, ulnar and radial nerves will then be isolated and redirected to discrete skin patches in the proximal residual forearm or proximal brachium. Coaptation of the FCR/ECRL, FDP/EDC, FPL/EPL and B/T muscles will then be performed to promote dynamic coupling of these agonist/antagonist pairs. The skin envelope will then be closed in layers over percutaneous drains.

Active Comparator: Control group
Standard amputation procedure
Procedure: Standard amputation procedure
Amputation is performed via standard techniques at either the BEA or AEA level. No construction of agonist-antagonist muscle pairs will be performed.




Primary Outcome Measures :
  1. Motor Unit Innervation [ Time Frame: 0-36 months ]
    Intact volitional activation of motor constructs, as assessed by electromyographic evidence of activation (muscle potentials measured in mV)

  2. Motor Unit Excursion [ Time Frame: 0-36 months ]
    Intact volitional activation of motor constructs with measurable excursion, as assessed by ultrasound (excursion measured in mm)

  3. Proprioception Recovery [ Time Frame: 0-36 months ]
    Manifestation of functional proprioception with motor unit activation, as evidenced by spatial limb position testing using a modified upper limb prosthesis (accurate limb positioning relative to target measured in mm)


Secondary Outcome Measures :
  1. Infection Rate [ Time Frame: 0-36 months ]
    Postoperative infection rate

  2. Delayed Wound Healing Rate [ Time Frame: 0-36 months ]
    Postoperative delayed wound healing rate

  3. Operative Revision Rate [ Time Frame: 0-36 months ]
    Subsequent rate of reoperation

  4. Seroma Rate [ Time Frame: 0-36 months ]
    Postoperative seroma rate

  5. Deep Vein Thrombosis Rate [ Time Frame: 0-36 months ]
    Postoperative deep vein thrombosis rate

  6. 30-Day Mortality Rate [ Time Frame: 0-36 months ]
    Postoperative 30-day mortality rate

  7. General Health Status [ Time Frame: 0-36 Months ]
    Preoperative and postoperative general health status, as assessed by four validated surveys

  8. Muscle Atrophy [ Time Frame: 0-36 Months ]
    Postoperative muscle atrophy, as evidenced by changes in muscle volume

  9. Sensory Recovery [ Time Frame: 0-36 Months ]
    Postoperative sensory recovery, as assessed by cutaneous stimulation



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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:

  • Males or females between the ages of 18 and 65
  • Candidates for elective unilateral or bilateral upper extremity amputation at either the above elbow or below elbow level due to traumatic injury, congenital limb deformities or progressive arthritis
  • Must demonstrate sufficiently sound health to undergo the operative procedure, including adequate cardiopulmonary stability to undergo general anesthesia (specifically, American Society of Anesthesiology Class I or II)
  • Must have intact inherent wound healing capacity
  • Must demonstrate adequate communication skills to convey the status of their sensorimotor recovery throughout the postoperative phase,
  • Must exhibit proper level of motivation to comply with postoperative follow up requirements
  • Must be willing to also consent to study activities taking place at Massachusetts Institute of Technology (approved under same IRB protocol via ceded IRB review) as some outcome measures will be assessed at that site

Exclusion Criteria:

  • Patients beyond the stated age restrictions
  • Those with severe illness rendering them unable to undergo the operative procedure safely (e.g., unresolved sepsis or cardiopulmonary instability manifest as documented coronary artery disease and/or chronic obstructive pulmonary disease)
  • Patients with active infections, particularly deep infections in the arm to be amputated
  • Patients who are taking immunosuppressive agents
  • Patients with impairment in inherent wound healing pathways, such as those with primary connective tissue disorders or those on chronic steroid therapy
  • Patients with extensive peripheral neuropathies (diabetic or otherwise) that would potentially inhibit appropriate reinnervation of the surgical constructs
  • Active smokers; those patients willing to undergo tobacco cessation will need to be completely abstinent from tobacco use for at least 6 weeks preoperatively
  • Patients who are unable to provide informed consent and those with a demonstrated history of poor compliance
  • Pregnant women will not be considered due to the potential risks of general anesthesia

Patients will not be excluded from participation in the study on the grounds of minority status, religious status, race or gender. Non-English speaking patients will not be excluded from the study; interpreters will be made available to them for translation of both verbal interactions and written documents.


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): NCT03882073


Contacts
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Contact: Matthew J Carty, MD 6179834555 mcarty@partners.org

Locations
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United States, Maryland
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889
Contact: Benjamin K Potter, MD FACS COL MC USA    3012954290    benjamin.k.potter.mil@mail.mil   
United States, Massachusetts
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Matthew J Carty, MD    617-983-4522    mcarty@partners.org   
Massachusetts Institute of Technology Media Lab 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 Army Institute of Research (WRAIR)
Investigators
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Principal Investigator: Matthew J Carty, MD Brigham and Women's Hospital
Publications:

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Responsible Party: Matthew Carty, Director, Lower Extremity Transplant Program, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03882073    
Other Study ID Numbers: 2018p001893
CDMRP-170384 ( Other Grant/Funding Number: Department of Defense )
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: March 15, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan for individual participant data sharing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No