Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 12:57 AM
Study NCT ID:
NCT03533634
Status:
COMPLETED
Last Update Posted:
2018-05-23
First Post:
2018-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Functional Outcome in Midshaft Clavicle Fracture, Treated With Superior Versus Anteroinferior Reconstruction Plate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'the patient and the outcomes analyzer were masked'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-10', 'studyFirstSubmitDate': '2018-04-30', 'studyFirstSubmitQcDate': '2018-05-10', 'lastUpdatePostDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disabilities of Arm Shoulder and Hand score (DASH)', 'timeFrame': '30 days after surgery', 'description': 'we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability'}, {'measure': 'Disabilities of Arm Shoulder and Hand score (DASH)', 'timeFrame': '60 days after surgery', 'description': 'we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability'}, {'measure': 'Disabilities of Arm Shoulder and Hand score (DASH)', 'timeFrame': '90 days after surgery', 'description': 'we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability'}, {'measure': 'Disabilities of Arm Shoulder and Hand score (DASH)', 'timeFrame': '365 days after surgery', 'description': 'we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability'}], 'secondaryOutcomes': [{'measure': 'Visual Analogue Scale score (VAS)', 'timeFrame': '30 days after surgery', 'description': 'we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain'}, {'measure': 'Visual Analogue Scale score (VAS)', 'timeFrame': '60 days after surgery', 'description': 'we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain'}, {'measure': 'Visual Analogue Scale score (VAS)', 'timeFrame': '90 days after surgery', 'description': 'we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain'}, {'measure': 'Visual Analogue Scale score (VAS)', 'timeFrame': '365 days after surgery', 'description': 'we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['midshaft clavicle fracture', 'functional outcome', 'anteroinferior plate', 'superior plate', 'reconstruction plate'], 'conditions': ['Closed Fracture of Shaft of Clavicle']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the functional outcome in patients with a midshaft clavicle fracture treated with to different techniques. the first one was placing a 3.5mm reconstruction plate in the superior side of the clavicle and the second one placing the same 3.5mm reconstruction plate in the anteroinferior side of the clavicle. the patients had the same rehabilitation program and evaluated with functional scores at 30, 60, 90 and 365 days after surgery. biomechanical studies have demonstrated more stable construct using an anteroinferior plate in clavicle fractures and we were trying to find out if it has a clinical relevance in patients with midshaft clavicle fractures.', 'detailedDescription': 'The purpose of this study was to evaluate the functional outcome in patients with a midshaft clavicle fracture treated with to different techniques.\n\nthe first technique was placing a 3.5mm reconstruction plate in the superior side of the clavicle and the second one placing the same 3.5mm reconstruction plate in the anteroinferior side of the clavicle.\n\nthe patients had the same rehabilitation program and evaluated with Disabilities Arm Shoulder and Hand functional outcome score and Visual Analogue Score for pain at 30, 60, 90 and 365 days after surgery.\n\nbiomechanical studies have demonstrated more stable construct using an anteroinferior plate in clavicle fractures and we were trying to find out if it has a clinical relevance in patients with midshaft clavicle fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* traumatic fracture\n* ao 15 b1 and 15 b2\n* no previous shoulder lesions\n* no further 7 days fractures\n* closed fracture\n\nExclusion Criteria:\n\n* calcium diseases\n* Previous shoulder pain\n* other fractures associated'}, 'identificationModule': {'nctId': 'NCT03533634', 'briefTitle': 'Functional Outcome in Midshaft Clavicle Fracture, Treated With Superior Versus Anteroinferior Reconstruction Plate', 'organization': {'class': 'OTHER', 'fullName': 'UMAE Hospital de Traumatologia y Ortopedia de Puebla'}, 'officialTitle': 'Functional Outcome in Midshaft Clavicle Fracture Patients, Treated With Superior Versus Anteroinferior Reconstruction Plate. Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'UMAE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'superior group', 'description': 'this group with midshaft clavicle fracture were treated with superior reconstruction plate', 'interventionNames': ['Procedure: Open Reduction Internal Fixation superior plate']}, {'type': 'EXPERIMENTAL', 'label': 'anteroinferior group', 'description': 'this group with midshaft clavicle fracture were treated with anteroinferior reconstruction plate', 'interventionNames': ['Procedure: Open Reduction Internal Fixation anteroinferior plate']}], 'interventions': [{'name': 'Open Reduction Internal Fixation superior plate', 'type': 'PROCEDURE', 'description': '3.5mm superior reconstruction plate', 'armGroupLabels': ['superior group']}, {'name': 'Open Reduction Internal Fixation anteroinferior plate', 'type': 'PROCEDURE', 'description': '3.5mm anteroinferior reconstruction plate', 'armGroupLabels': ['anteroinferior group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jose A Manrique, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMAE Hospital de Traumatologia y Ortopedia de Puebla'}, {'name': 'Gustavo Rivera Saldivar, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'UMAE Hospital de Traumatologia y Ortopedia de Puebla'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMAE Hospital de Traumatologia y Ortopedia de Puebla', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jose Antonio Manrique', 'investigatorAffiliation': 'UMAE Hospital de Traumatologia y Ortopedia de Puebla'}}}}