Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT03882073

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

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2019-05-01

Completion Date

2026-09-30

Last Updated

2025-10-20

Healthy Volunteers

Yes

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.

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.

Locations (4)

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Massachusetts General Hospital