AMI Construction in Lower Extremity Residual Limbs

Amputation Clinical Trial

Official title:

A Novel Approach to Lower Extremity Residual Limb Revision to Augment Volitional Motor Control, Restore Proprioception and Reverse Limb Atrophy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04063592
• Other study ID #: 2019P001681
• Secondary ID: CDMRP-180114
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: December 2023
• Source: Brigham and Women's Hospital
• Contact: Matthew J Carty, MD
• Phone: 6179834555
• Email: mcarty[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

The hypothesis of this research protocol is that we will be able to modify the residual limbs of patients who have already undergone lower extremity amputations so as to include biological actuators that will enable the successful employment of next generation lower extremity prostheses, diminish/eliminate phantom limb pain, restore proprioception and regenerate lost muscle mass. The specific aims of the project are as follows:

1. To develop a standardized operative technique for both above knee (AK) and below knee (BK) amputation revision procedures that includes AMIs to restore musculotendinous proprioceptive capabilities

2. To assess the capacity for these actuators to provide enhanced motor control and sensory feedback, as well as ablate phantom limb symptomatology and augment residual limb muscle mass

3. To determine the reinnervation time course and longevity of these biological constructs

4. To validate the functional and somatosensory superiority of the proposed revision technique over standard approaches to BKA and AKA

5. To develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputation

Intervention

Procedure:
• Residual limb revision
Surgical procedure involving construction of agonist-antagonist myoneural interfaces (AMIs)

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts Institute of Technology	Cambridge	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Massachusetts Institute of Technology, United States Department of Defense, Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Complications	Delayed wound healing, infection, need for additional surgery, PE/DVT, death	Years 1-3