Health TrialsbyHealthPanel

AMI Construction in Lower Extremity Residual Limbs

ConditionAmputation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBrigham and Women's Hospital

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Between the ages of 18-65

Has already undergone a standard AKA or BKA procedure

Intractable pain

Deterioration of skin on or around stump

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Residual limb revision

    Procedure/Surgery

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

Treatment groups

26 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Years 1-3
2

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.

Time frame
Years 1-3
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.

Time frame
Years 1-3
4

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.

Time frame
Years 1-3

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Massachusetts Institute of Technology

Collaborator

Source ClinicalTrials.gov
Apply now