Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-26 @ 12:07 AM
Study NCT ID:
NCT05640466
Status:
COMPLETED
Last Update Posted:
2024-02-23
First Post:
2022-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reduction and Fixation of Metatarsal Neck Fracture by Metaizeau's Technique
Sponsor:
Organization:
Raw JSON
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The diameter of the Kirschner wires to be used should be related to the size of the fractured metatarsal medullar cavity. Kirschner wire will be driven anterograde, with the help of an X-ray image intensifier.\n\nSubsequently, the wire will be rotated 180 to direct its end to the dorsum of the foot so as to provoke a translation effect on the metatarsal head in order to obtain the head reduction, and maintained this reduction with the Kirschner wire.\n\nReduction and fixation of metatarsal neck fracture by metaizeau's technique: Reduction and fixation of metatarsal neck fracture by metaizeau's technique", 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Bone infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20'}], 'seriousEvents': [{'term': 'stifness foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time of Union', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adult Patient With Displaced Metatarsal Head Fractures', 'description': "A Kirschner wire with its distal end is placed showing a small bend into the medullar cavity through the lateral margin of the proximal metaphysis of the affected metatarsal using a 5mm skin incision at that level. The skin incision was made over the interosseus space, so as to use one incision for the two neighbouring metatarsal bones. The diameter of the Kirschner wires to be used should be related to the size of the fractured metatarsal medullar cavity. Kirschner wire will be driven anterograde, with the help of an X-ray image intensifier.\n\nSubsequently, the wire will be rotated 180 to direct its end to the dorsum of the foot so as to provoke a translation effect on the metatarsal head in order to obtain the head reduction, and maintained this reduction with the Kirschner wire.\n\nReduction and fixation of metatarsal neck fracture by metaizeau's technique: Reduction and fixation of metatarsal neck fracture by metaizeau's technique"}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '1.48', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks postoperatively', 'description': 'Time taken from operation till full fracture union', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Time to Range of Motion (ROM) Start', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adult Patient With Displaced Metatarsal Head Fractures', 'description': "A Kirschner wire with its distal end is placed showing a small bend into the medullar cavity through the lateral margin of the proximal metaphysis of the affected metatarsal using a 5mm skin incision at that level. The skin incision was made over the interosseus space, so as to use one incision for the two neighbouring metatarsal bones. The diameter of the Kirschner wires to be used should be related to the size of the fractured metatarsal medullar cavity. Kirschner wire will be driven anterograde, with the help of an X-ray image intensifier.\n\nSubsequently, the wire will be rotated 180 to direct its end to the dorsum of the foot so as to provoke a translation effect on the metatarsal head in order to obtain the head reduction, and maintained this reduction with the Kirschner wire.\n\nReduction and fixation of metatarsal neck fracture by metaizeau's technique: Reduction and fixation of metatarsal neck fracture by metaizeau's technique"}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '0.51', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks post-operatively', 'description': 'Time taken from operation till starting range of motion (ROM)', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adult Patient With Displaced Metatarsal Head Fractures', 'description': "A Kirschner wire with its distal end is placed showing a small bend into the medullar cavity through the lateral margin of the proximal metaphysis of the affected metatarsal using a 5mm skin incision at that level. The skin incision was made over the interosseus space, so as to use one incision for the two neighbouring metatarsal bones. The diameter of the Kirschner wires to be used should be related to the size of the fractured metatarsal medullar cavity. Kirschner wire will be driven anterograde, with the help of an X-ray image intensifier.\n\nSubsequently, the wire will be rotated 180 to direct its end to the dorsum of the foot so as to provoke a translation effect on the metatarsal head in order to obtain the head reduction, and maintained this reduction with the Kirschner wire.\n\nReduction and fixation of metatarsal neck fracture by metaizeau's technique: Reduction and fixation of metatarsal neck fracture by metaizeau's technique"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'All participants came to sohag university hospital', 'preAssignmentDetails': 'no participant excluded'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Adult Patient With Displaced Metatarsal Head Fractures', 'description': "A Kirschner wire with its distal end is placed showing a small bend into the medullar cavity through the lateral margin of the proximal metaphysis of the affected metatarsal using a 5mm skin incision at that level. The skin incision was made over the interosseus space, so as to use one incision for the two neighbouring metatarsal bones. The diameter of the Kirschner wires to be used should be related to the size of the fractured metatarsal medullar cavity. Kirschner wire will be driven anterograde, with the help of an X-ray image intensifier.\n\nSubsequently, the wire will be rotated 180 to direct its end to the dorsum of the foot so as to provoke a translation effect on the metatarsal head in order to obtain the head reduction, and maintained this reduction with the Kirschner wire.\n\nReduction and fixation of metatarsal neck fracture by metaizeau's technique: Reduction and fixation of metatarsal neck fracture by metaizeau's technique"}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27.1', 'spread': '12.11', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Egypt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-01', 'size': 444285, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-10T12:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Single intervention no masking'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-13', 'studyFirstSubmitDate': '2022-11-22', 'resultsFirstSubmitDate': '2023-07-13', 'studyFirstSubmitQcDate': '2022-12-03', 'lastUpdatePostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-13', 'studyFirstPostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of Union', 'timeFrame': '8 weeks postoperatively', 'description': 'Time taken from operation till full fracture union'}, {'measure': 'Time to Range of Motion (ROM) Start', 'timeFrame': '8 weeks post-operatively', 'description': 'Time taken from operation till starting range of motion (ROM)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Displaced Metatarsal Neck Fracture']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mattioli1885journals.com/index.php/actabiomedica/article/view/9724', 'label': 'Central metatarsal fractures: a review and current concepts'}, {'url': 'https://link.springer.com/article/10.4103/ortho.IJOrtho_563_17', 'label': 'Management of Talar Body Fractures'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8822033/', 'label': 'AOFAS Functional Scoring After Antegrade K Wires Fixation of Multiple Metatarsal Neck Fracture: A Case Report'}]}, 'descriptionModule': {'briefSummary': "Metatarsal fractures represent 3-7% of all fractures of the body and 35% of fractures of the foot and have a rate of 75 new cases per 10,000 persons per year.\n\nThe goal of treatment is to achieve a correct reduction of fracture, to avoid prolonged disability and preservation of both soft tissues and bony alignment.\n\nMetaizeau's technique in these fracture of the metatarsal bone respects the soft tissues surrounding the fracture and the periosteum at the fracture site.", 'detailedDescription': "Metatarsal fractures represent 3-7% of all fractures of the body and 35% of fractures of the foot and have a rate of 75 new cases per 10,000 persons per year.\n\nMetatarsal fractures have been considered of little importance by many authors over the years, and have received little attention. That is why little literature about operative management of metatarsal fractures can be found (apart from the first and fifth metatarsal bones).\n\nGenerally, these are non-displaced fractures. When these fractures show some displacement, reasonable alignment must be obtained because the metatarsals' capability for remodelling is extensive but not infinite.\n\nDisplaced metatarsal neck fractures are usually treated by means of retrograde Kirschner wires, which generally requires an open reduction at the fracture site due to the difficulty of reducing the metatarsal head.\n\nMetaizeau's technique can be applied to reduce the displaced metatarsal head distally from the fracture in an easier way and to keep the fracture site closed, as compared with retrograde Kirschner wires method . Open reduction was unnecessary in all cases. This technique permitted correct control of the distal fracture fragment, obtained good reduction of the metatarsal heads without opening the fracture site, and with no lesion of the capsuloligamentous complex of metatarsophalangeal joint. Metaizeau's technique is a valid alternative to retrograde method.\n\nThe goal of treatment is to achieve a correct reduction of fracture, to avoid prolonged disability and preservation of both soft tissues and bony alignment. Metaizeau's technique in these fracture of the metatarsal bone respects the soft tissues surrounding the fracture and the periosteum at the fracture site."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient with displaced fracture neck of the 2nd, 3rd or 4th metatarsal\n\nExclusion Criteria:\n\n* Poly\\_traumatized patient .\n* Patient with fracture first and fifth metatarsal bone .\n* Fracture shaft metatarsal bone , first MB, fifth MB.\n* Open fractures of the foot .\n* Intraarticular fracture of metatarsals .\n* Lisfranc fracture .\n* Segmental fracture of the metatarsals'}, 'identificationModule': {'nctId': 'NCT05640466', 'briefTitle': "Reduction and Fixation of Metatarsal Neck Fracture by Metaizeau's Technique", 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': "Reduction and Fixation of Metatarsal Neck Fracture by Metaizeau's Technique", 'orgStudyIdInfo': {'id': 'Sohagu1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Adult patient with displaced metatarsal head fractures', 'description': 'A Kirschner wire with its distal end is placed showing a small bend into the medullar cavity through the lateral margin of the proximal metaphysis of the affected metatarsal using a 5mm skin incision at that level. The skin incision was made over the interosseus space, so as to use one incision for the two neighbouring metatarsal bones. The diameter of the Kirschner wires to be used should be related to the size of the fractured metatarsal medullar cavity. Kirschner wire will be driven anterograde, with the help of an X-ray image intensifier.\n\nSubsequently, the wire will be rotated 180 to direct its end to the dorsum of the foot so as to provoke a translation effect on the metatarsal head in order to obtain the head reduction, and maintained this reduction with the Kirschner wire.', 'interventionNames': ["Device: Reduction and fixation of metatarsal neck fracture by metaizeau's technique"]}], 'interventions': [{'name': "Reduction and fixation of metatarsal neck fracture by metaizeau's technique", 'type': 'DEVICE', 'description': "Reduction and fixation of metatarsal neck fracture by metaizeau's technique", 'armGroupLabels': ['Adult patient with displaced metatarsal head fractures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82511', 'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag university', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopedic Surgery Resident', 'investigatorFullName': 'Hussien Sedik Mohamed', 'investigatorAffiliation': 'Sohag University'}}}}