Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-18 @ 7:31 PM
Study NCT ID:
NCT00871468
Status:
UNKNOWN
Last Update Posted:
2017-10-13
First Post:
2009-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plating Clavicle Fractures
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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-11', 'studyFirstSubmitDate': '2009-03-26', 'studyFirstSubmitQcDate': '2009-03-27', 'lastUpdatePostDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Less irritation with anterior-inferior plating and less need for hardware removal.', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'DASH (Disability of Arm, Shoulder and Hand) and constant scores', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Clavicle Fracture, Non Union/Malunion']}, 'descriptionModule': {'briefSummary': 'The anterior-inferior clavicle plate position will have a lower rate of soft tissue irritation that limits activity and/or requires hardware removal compared to superior plate position.', 'detailedDescription': "Compare the rates of soft-tissue irritation with two different methods of plating for clavicle fractures. Patients will be randomized to anterior-inferior or superior plating. Validated shoulder scoring systems will be used to assess outcome. Specific follow-up questions will address the patient's ability to wear his/her uniform, body armor, ruck sack, and other shoulder-borne equipment over the surgical site."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active duty, Reservists, National Guard service members\n* completely displaced shaft fracture of the clavicle (no cortical contact between the main proximal and distal fragments)\n* a fracture involving the middle third of the clavicle (a fracture amenable to plate fixation with a minimum of three screws in each proximal and distal fragment)\n* chronic nonunion and malunion fractures\n* no medical contraindications to general anesthesia\n* provided informed consent.\n\nExclusion Criteria:\n\n* an age of less than eighteen years or greater than sixty five years\n* a fracture in the proximal or distal third of the clavicle not amenable to plating\n* a pathological fracture\n* an associated head injury (a Glasgow Coma Scale score of \\<15 at 21 days after injury)\n* an inability to comply with followup\n* a medical contraindication to surgery and/or anesthesia (such as heart disease, renal failure, or active chemotherapy)\n* a lack of consent.'}, 'identificationModule': {'nctId': 'NCT00871468', 'briefTitle': 'Plating Clavicle Fractures', 'organization': {'class': 'FED', 'fullName': 'United States Army Institute of Surgical Research'}, 'officialTitle': 'Does Anterior-Inferior Clavicle Plating Have a Lower Rate of Soft Tissue Irritation Compared to Superior Plating? A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': 'H-08-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'superior plate', 'description': 'Clavicle plate on the superior surface of the bone', 'interventionNames': ['Procedure: superior plate']}, {'type': 'EXPERIMENTAL', 'label': 'anterior inferior plate', 'description': 'plate placed on anterior inferior surface of bone', 'interventionNames': ['Procedure: anterior-inferior plate']}], 'interventions': [{'name': 'superior plate', 'type': 'PROCEDURE', 'description': 'Open reduction internal fixation (ORIF) clavicle with superior plate', 'armGroupLabels': ['superior plate']}, {'name': 'anterior-inferior plate', 'type': 'PROCEDURE', 'description': 'ORIF clavicle with anterior inferior plate', 'armGroupLabels': ['anterior inferior plate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79920-5001', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'William Beaumont Army Medical Center', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '78234', 'city': 'Fort Sam Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'US Army Institute of Surgical Research', 'geoPoint': {'lat': 29.45303, 'lon': -98.4417}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United States Army Institute of Surgical Research', 'class': 'FED'}, 'collaborators': [{'name': 'William Beaumont Army Medical Center', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}