AMI Construction in Lower Extremity Residual Limbs

NCT04063592 | Recruiting DMC

• 2 other identifiers: 2019P001681CDMRP-180114
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Limb Morphology and Changes in Muscle Volume

  Clinical examination and images from CT/MRI will be combined to construct a holistic view of the morphology of the residual limb. Imaging studies and limb measurements taken in clinic will also be used to measure muscle atrophy/hypertrophy over time.

  Years 1-3

• Degree of Motor Activation of AMI Muscles and Volitional Control of Phantom Limb

  Clinical examination will confirm the sliding motion of the AMI constructs with radiologic evaluation measuring the length of muscle excursion through each construct. Functional testing and testing using a prosthesis will determine how well a patient is able to volitionally control the AMI muscles.

  Years 1-3

• Evidence of Proprioception

  Subjective reporting combined with tests run using a prosthesis will indicate if proprioception is still intact after surgery. Results will be confirmed by monitoring brain activity during limb movement activities via fMRI.

  Years 1-3

• Evidence of Sensory Perception

  Subjective reporting and clinical tests of Semmes-Weinstein and two-point discrimination will determine if the patient has sensory perception on the residual limb.

  Years 1-3

• General Health

  Patient-reported outcomes metrics from five validated tests (SIP136, EQ-5D, SF-36, LEFS, PROMIS) will be combined to create an overall picture of patients' general health during and after their recovery.

  Years 1-3

• Complications

  Delayed wound healing, infection, need for additional surgery, PE/DVT, death

  Years 1-3

Study Arms (1)

Intervention

EXPERIMENTAL

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

Procedure: Residual limb revision

Interventions

Residual limb revision PROCEDURE

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

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Massachusetts Institute of Technology: collaborator
• Walter Reed National Military Medical Center: collaborator
• United States Department of Defense: collaborator

Study Sites (3)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

NOT YET RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Massachusetts Institute of Technology

Cambridge, Massachusetts, 02139, United States

RECRUITING

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Matthew J Carty, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew J Carty, MD

CONTACT

6179834555; mcarty@partners.org

Research Coordinators

CONTACT

limbrestoration@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective clinical trial in which intervention subjects will serve as their own control

Study Record Dates

• First Submitted: June 15, 2019
• First Posted: August 21, 2019
• Study Start: February 24, 2020
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)