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

NARecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

May 1, 2019

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Amputation
Interventions
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.

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.

Trial Locations (4)

20889

RECRUITING

Walter Reed National Military Medical Center, Bethesda

02114

RECRUITING

Brigham & Women's Hospital, Boston

RECRUITING

Massachusetts General Hospital, Boston

02139

RECRUITING

Massachusetts Institute of Technology Media Lab, Cambridge

All Listed Sponsors
collaborator

Massachusetts Institute of Technology

OTHER

collaborator

Walter Reed Army Institute of Research (WRAIR)

FED

collaborator

Massachusetts General Hospital

OTHER

lead

Brigham and Women's Hospital

OTHER