Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
Study NCT ID:
NCT04063592
Status:
RECRUITING
Last Update Posted:
2025-10-17
First Post:
2019-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AMI Construction in Lower Extremity Residual Limbs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010591', 'term': 'Phantom Limb'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective clinical trial in which intervention subjects will serve as their own control'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-15', 'studyFirstSubmitDate': '2019-06-15', 'studyFirstSubmitQcDate': '2019-08-16', 'lastUpdatePostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Limb Morphology and Changes in Muscle Volume', 'timeFrame': 'Years 1-3', 'description': '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.'}, {'measure': 'Degree of Motor Activation of AMI Muscles and Volitional Control of Phantom Limb', 'timeFrame': 'Years 1-3', 'description': '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.'}, {'measure': 'Evidence of Proprioception', 'timeFrame': 'Years 1-3', 'description': '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.'}, {'measure': 'Evidence of Sensory Perception', 'timeFrame': 'Years 1-3', 'description': 'Subjective reporting and clinical tests of Semmes-Weinstein and two-point discrimination will determine if the patient has sensory perception on the residual limb.'}, {'measure': 'General Health', 'timeFrame': 'Years 1-3', 'description': "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."}, {'measure': 'Complications', 'timeFrame': 'Years 1-3', 'description': 'Delayed wound healing, infection, need for additional surgery, PE/DVT, death'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Amputation', 'Residual limb pain', 'Phantom pain', 'Residual limb atrophy', 'Prosthesis control'], 'conditions': ['Amputation']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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:\n\n1. 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\n2. 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\n3. To determine the reinnervation time course and longevity of these biological constructs\n4. To validate the functional and somatosensory superiority of the proposed revision technique over standard approaches to BKA and AKA\n5. To develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18-65\n* Has already undergone a standard AKA or BKA procedure\n* Suffers from symptoms such as:\n\n * Intractable pain\n * Deterioration of skin on or around stump\n * Suffering from other sources of discomfort arising from stump\n* Intact inherent wound healing\n* Adequate communication skills\n* High motivation\n\nExclusion Criteria:\n\n* Inadequate health to undergo operative procedure using standard anesthesia (i.e. cardiopulmonary)\n* Individuals with impaired wound healing\n* Individuals suffering from extensive peripheral neuropathies\n* Active smokers\n* Individuals with a history of poor compliance\n* Women who are pregnant or plan to become pregnant before surgical intervention'}, 'identificationModule': {'nctId': 'NCT04063592', 'briefTitle': 'AMI Construction in Lower Extremity Residual Limbs', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'A Novel Approach to Lower Extremity Residual Limb Revision to Augment Volitional Motor Control, Restore Proprioception and Reverse Limb Atrophy', 'orgStudyIdInfo': {'id': '2019P001681'}, 'secondaryIdInfos': [{'id': 'CDMRP-180114', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Subjects undergoing the proposed operative intervention. Intervention patients will serve as their own control for all outcome measures', 'interventionNames': ['Procedure: Residual limb revision']}], 'interventions': [{'name': 'Residual limb revision', 'type': 'PROCEDURE', 'description': 'Surgical procedure involving construction of agonist-antagonist myoneural interfaces (AMIs)', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20889', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kyle Potter, MD', 'role': 'CONTACT', 'email': 'benjamin.k.potter.mil@mail.mil'}], 'facility': 'Walter Reed National Military Medical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew J Carty, MD', 'role': 'CONTACT', 'email': 'mcarty@partners.org', 'phone': '617-983-4555'}], 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02139', 'city': 'Cambridge', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hugh Herr, PhD', 'role': 'CONTACT', 'email': 'hherr@media.mit.edu', 'phone': '617-314-3661'}], 'facility': 'Massachusetts Institute of Technology', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}], 'centralContacts': [{'name': 'Matthew J Carty, MD', 'role': 'CONTACT', 'email': 'mcarty@partners.org', 'phone': '6179834555'}, {'name': 'Research Coordinators', 'role': 'CONTACT', 'email': 'limbrestoration@bwh.harvard.edu'}], 'overallOfficials': [{'name': 'Matthew J Carty, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be available to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Massachusetts Institute of Technology', 'class': 'OTHER'}, {'name': 'Walter Reed National Military Medical Center', 'class': 'FED'}, {'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Matthew Carty', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}