RecruitingNot ApplicableNCT04063592
AMI Construction in Lower Extremity Residual Limbs
A Novel Approach to Lower Extremity Residual Limb Revision to Augment Volitional Motor Control, Restore Proprioception and Reverse Limb Atrophy
Sponsor
Brigham and Women's Hospital
Enrollment
26 participants
Start Date
Feb 24, 2020
Study Type
INTERVENTIONAL
Conditions
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
Eligibility
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria9
- 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 Criteria6
- 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
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Interventions
PROCEDUREResidual limb revision
Surgical procedure involving construction of agonist-antagonist myoneural interfaces (AMIs)
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT04063592
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