AMI Construction in Lower Extremity Residual Limbs

Mass General Brigham

Status: Enrolling

Conditions: Amputation

Treatments: Procedure: Residual limb revision

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04063592

CDMRP-180114 (Other Grant/Funding Number)

2019P001681

Details and patient eligibility

About

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

Full 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

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Intervention

Experimental group

Description:

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

Treatment:

Procedure: Residual limb revision