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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Brigham and Women's Hospital
Study ID
NCT03882073
Status
Recruiting
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Conditions

  • Amputation

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Modified amputation procedure — 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.
  • Standard amputation procedure — PROCEDURE
    Amputation is performed via standard techniques at either the BEA or AEA level. No construction of agonist-antagonist muscle pairs will be performed.

Study Details

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.

Key Dates

Start date
May 1, 2019
Status verified
Oct 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention group
    Modified amputation procedure
  • Active Comparator: Control group
    Standard amputation procedure

Primary Outcome Measure

Motor Unit Innervation [ Time Frame: 0-36 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Walter Reed National Military Medical CenterBethesdaMaryland20889
Benjamin K Potter, MD FACS COL MC USA
[email protected]
3012954290
Brigham & Women's HospitalBostonMassachusetts02114
Matthew J Carty, MD
[email protected]
617-983-4522
Massachusetts General HospitalBostonMassachusetts02114
Kyle Eberlin, MD
617-643-4902
Massachusetts Institute of Technology Media LabCambridgeMassachusetts02139
Hugh Herr, PhD
[email protected]
617-314-3661

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By research site
Walter Reed National Military Medical Center· Bethesda, MDBrigham & Women's Hospital· Boston, MAMassachusetts General Hospital· Boston, MAMassachusetts Institute of Technology Media Lab· Cambridge, MA

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