Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-01-06 @ 10:50 AM
Study NCT ID:
NCT06923566
Status:
COMPLETED
Last Update Posted:
2025-04-11
First Post:
2025-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeted Muscle Reinnervation in the Hand for the Managment of Symptomatic Neuroma Following Digit and Hand Amputations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009463', 'term': 'Neuroma'}], 'ancestors': [{'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2025-03-06', 'studyFirstSubmitQcDate': '2025-04-04', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuroma incidence', 'timeFrame': 'through study completion, an average of 1 year', 'description': "Neuroma incidence post TMR operation is recorded via Tinel's sign"}, {'measure': 'Neuroma recurrence', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Neuroma recurrence in cases of 2ry TMR cases'}, {'measure': 'Pain intensity', 'timeFrame': 'will be taken at intervals over time (1 month, 3 months,6 months, 9 months,1 year until the conclusion of the study', 'description': 'measured using pain rating numerical scale commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable'}, {'measure': 'Pain medication usage type', 'timeFrame': 'Followed up at intervals over time (1 month, 3 months,6 months, 9 months,1 year until the conclusion of the study', 'description': 'pain medication usage type recorded'}, {'measure': 'Pain medication usage frequency', 'timeFrame': 'Followed up at intervals over time (1 month, 3 months,6 months, 9 months,1 year until the conclusion of the study', 'description': 'pain medication usage frequency recorded'}, {'measure': 'Pain character', 'timeFrame': 'will be taken at intervals over time (1 month, 3 months,6 months, 9 months,1 year until the conclusion of the study', 'description': 'Leeds Assessment of neuropathic symptoms and signs pain scale is a valuable tool designed to evaluate and categorize pain. Its primary purpose is to determine if nerve damage is the primary cause of the pain, distinguishing between neuropathic and nociceptive pain.\n\nThe scale comprises seven items, divided into two sections. The first part consists of five questions related to symptoms experienced by the individual. The second part involves two clinical examination items that are typically conducted in collaboration with a healthcare provider.\n\nA score of 12 or more on this scale confirms a diagnosis of neuropathic pain to some degree. Scores below 12 are less likely to show neuropathic pain'}, {'measure': 'Pain character', 'timeFrame': 'will be taken at intervals over time (1 month, 3 months,6 months, 9 months,1 year until the conclusion of the study', 'description': 'The McGill Pain Questionnaire is a well-known assessment tool used to quantify and understand the subjective experience of pain. It primarily consists of three major categories of word descriptors-sensory affective, and evaluative-through which patients can express and specify their pain experience. In addition to these descriptors, the questionnaire includes an intensity scale and other items to further capture the properties of the pain being experienced.'}], 'secondaryOutcomes': [{'measure': 'operative time', 'timeFrame': 'intraoperative', 'description': 'measuring the operative time'}, {'measure': 'Rate of infection', 'timeFrame': 'up to 30 days postoperative', 'description': 'surgical site infections were recorded'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Targeted muscle reinnervation', 'neuroma', 'amputation'], 'conditions': ['Targeted Muscle Reinervation', 'Digital Amputation', 'Neuroma']}, 'descriptionModule': {'briefSummary': 'Neuromas are a common complication after digital and hand amputations, resulting in significant pain, discomfort, and functional impairment. Various management methods are available, including surgical excision, nerve blocks, and nerve stump protectors, but these treatments may have limited success rates and potential complications. Targeted muscle reinnervation (TMR) is a promising technique that involves surgically rerouting a severed nerve into a nearby muscle, which can prevent the formation of neuromas and provide improved muscle function'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Arabic or English speaking individuals\n* An upper limb amputation distal to the wrist crease\n* A symptomatic neuroma within the hand or digits: defined as patient-reported localized pain consistent with a clinical exam of a neuroma pain.There must be a supporting Tinel's sign on physical exam.\n\nExclusion Criteria:\n\n* Cognitive impairment for better assessment of patient reported outcomes and filling questionnaires and signing consents"}, 'identificationModule': {'nctId': 'NCT06923566', 'briefTitle': 'Targeted Muscle Reinnervation in the Hand for the Managment of Symptomatic Neuroma Following Digit and Hand Amputations', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Targeted Muscle Reinnervation in the Hand for the Managment of Symptomatic Neuroma Following Digit and Hand Amputations, A Prospective Case Series', 'orgStudyIdInfo': {'id': 'FMASU MD 145/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'targeted muscle reinervation post digit amputation group', 'description': 'In 1ry TMR ,after the amputation is performed by the standard method , transected nerves will be replanted micro surgically to motor entry points (MEPS)in the hand as predetermined by Daugherty et al , Motor branches in the recipient muscles could be determined by a nerve stimulator intraoperatively.\n\nIn 2ry TMR , neuroma site will be explored and it will be excised ,the distal end of the transected nerve will be connected micro surgically to the nearest MEPS', 'interventionNames': ['Procedure: Targeted muscle reinnervation']}], 'interventions': [{'name': 'Targeted muscle reinnervation', 'type': 'PROCEDURE', 'description': 'In 1ry TMR ,after the amputation is performed by the standard method , transected nerves will be replanted micro surgically to motor entry points (MEPS)in the hand as predetermined by Daugherty et al , Motor branches in the recipient muscles could be determined by a nerve stimulator intraoperatively.\n\nIn 2ry TMR , neuroma site will be explored and it will be excised ,the distal end of the transected nerve will be connected micro surgically to the nearest MEPS', 'armGroupLabels': ['targeted muscle reinervation post digit amputation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11655', 'city': 'Al ‘Abbāsīyah', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Ain Shams University Faculty of medicine', 'geoPoint': {'lat': 30.06907, 'lon': 31.27626}}], 'overallOfficials': [{'name': 'Ayman Ibrahim Fathy Aly Howeidy, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}