AMI Construction in Lower Extremity Residual Limbs
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|ClinicalTrials.gov Identifier: NCT04063592|
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : May 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Amputation||Procedure: Residual limb revision||Not Applicable|
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:
- 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
- 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
- To determine the reinnervation time course and longevity of these biological constructs
- To validate the functional and somatosensory superiority of the proposed revision technique over standard approaches to BKA and AKA
- To develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective clinical trial in which intervention subjects will serve as their own control|
|Masking:||None (Open Label)|
|Official Title:||A Novel Approach to Lower Extremity Residual Limb Revision to Augment Volitional Motor Control, Restore Proprioception and Reverse Limb Atrophy|
|Actual Study Start Date :||February 24, 2020|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||September 30, 2022|
Subjects undergoing the proposed operative intervention. Intervention patients will serve as their own control for all outcome measures
Procedure: Residual limb revision
Surgical procedure involving construction of agonist-antagonist myoneural interfaces (AMIs)
- Limb Morphology and Changes in Muscle Volume [ Time Frame: 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.
- Degree of Motor Activation of AMI Muscles and Volitional Control of Phantom Limb [ Time Frame: 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.
- Evidence of Proprioception [ Time Frame: 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.
- Evidence of Sensory Perception [ Time Frame: 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.
- General Health [ Time Frame: 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.
- Complications [ Time Frame: Years 1-3 ]Delayed wound healing, infection, need for additional surgery, PE/DVT, death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04063592
|Contact: Matthew J Carty, MDemail@example.com|
|Contact: Lori Bergerfirstname.lastname@example.org|
|United States, Maryland|
|Walter Reed National Military Medical Center||Not yet recruiting|
|Bethesda, Maryland, United States, 20889|
|Contact: Kyle Potter, MD email@example.com|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Matthew J Carty, MD 617-983-4555 firstname.lastname@example.org|
|Massachusetts Institute of Technology||Recruiting|
|Cambridge, Massachusetts, United States, 02139|
|Contact: Hugh Herr, PhD 617-314-3661 email@example.com|
|Principal Investigator:||Matthew J Carty, MD||Brigham and Women's Hospital|