AMI Construction in Lower Extremity Residual Limbs

Not Applicable

Recruiting

• Conditions: Amputation
• Interventions: Procedure: Residual limb revision

• Registration Number: NCT04063592
• Lead Sponsor: Brigham and Women's Hospital

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

Detailed 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

Study Timeline

• Study First Submitted: 2019-06-15
• Study First Submitted QC: 2019-08-16
• Study First Posted: 2019-08-21
• Study Start: 2020-02-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-05
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Residual limb revision	Subjects undergoing the proposed operative intervention. Intervention patients will serve as their own control for all outcome measures

Primary Outcome Measures

Name	Time	Method
Evidence of Sensory Perception	Years 1-3	Subjective reporting and clinical tests of Semmes-Weinstein and two-point discrimination will determine if the patient has sensory perception on the residual limb.
Limb Morphology and Changes in Muscle Volume	Years 1-3	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.
Evidence of Proprioception	Years 1-3	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.
General Health	Years 1-3	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.
Degree of Motor Activation of AMI Muscles and Volitional Control of Phantom Limb	Years 1-3	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.
Complications	Years 1-3	Delayed wound healing, infection, need for additional surgery, PE/DVT, death

Trial Locations

Locations (3)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Massachusetts Institute of Technology; 🇺🇸 Cambridge, Massachusetts, United States

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States