Recruiting

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT04063592

Conditions

Amputation

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Residual limb revision

Study Details

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

Conditions

Amputation

Study ID

NCT04063592

Start date

Feb 24, 2020

Status verified date

Jul, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

26 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

Subjects undergoing the proposed operative intervention. Intervention patients will serve as their own control for all outcome measures

Interventions

Residual limb revision

Surgical procedure involving construction of agonist-antagonist myoneural interfaces (AMIs)

Primary outcome measure

  • Limb Morphology and Changes in Muscle Volume [ Time Frame: Years 1-3 ]
  • Degree of Motor Activation of AMI Muscles and Volitional Control of Phantom Limb [ Time Frame: Years 1-3 ]
  • Evidence of Proprioception [ Time Frame: Years 1-3 ]
  • Evidence of Sensory Perception [ Time Frame: Years 1-3 ]
  • General Health [ Time Frame: Years 1-3 ]
  • Complications [ Time Frame: Years 1-3 ]

Central Contacts and Locations

Central contacts

Matthew J Carty, MD

6179834555mcarty@partners.org

Research Coordinators

limbrestoration@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Matthew J Carty, MD

617-983-4555mcarty@partners.org

Massachusetts Institute of Technology

Recruiting

Cambridge, Massachusetts, United States, 02139

Contacts

Hugh Herr, PhD

617-314-3661hherr@media.mit.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • Amputation
  • Residual limb pain
  • Phantom pain
  • Residual limb atrophy
  • Prosthesis control

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-07-09.