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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-180114 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| Massachusetts Institute of Technology | OTHER |
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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Subjects undergoing the proposed operative intervention. Intervention patients will serve as their own control for all outcome measures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Residual limb revision | Procedure | Surgical procedure involving construction of agonist-antagonist myoneural interfaces (AMIs) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Years 1-3 |
| 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. | Years 1-3 |
| 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. | Years 1-3 |
| 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. | Years 1-3 |
| General Health | 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. | Years 1-3 |
| Complications | Delayed wound healing, infection, need for additional surgery, PE/DVT, death |
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Inclusion Criteria:
Between the ages of 18-65
Has already undergone a standard AKA or BKA procedure
Suffers from symptoms such as:
Intact inherent wound healing
Adequate communication skills
High motivation
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew J Carty, MD | Contact | 6179834555 | mcarty@partners.org | |
| Research Coordinators | Contact | limbrestoration@bwh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matthew J Carty, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed National Military Medical Center | Not yet recruiting | Bethesda | Maryland | 20889 | United States |
Individual participant data will not be available to other researchers
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| ID | Term |
|---|---|
| D010591 | Phantom Limb |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Prospective clinical trial in which intervention subjects will serve as their own control
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| Years 1-3 |
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| Massachusetts Institute of Technology | Recruiting | Cambridge | Massachusetts | 02139 | United States |
|
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010146 | Pain |