Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-01-05 @ 5:11 PM
Study NCT ID:
NCT01405703
Status:
COMPLETED
Last Update Posted:
2015-07-09
First Post:
2011-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006987', 'term': 'Hypesthesia'}], 'ancestors': [{'id': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-08', 'studyFirstSubmitDate': '2011-07-27', 'studyFirstSubmitQcDate': '2011-07-28', 'lastUpdatePostDateStruct': {'date': '2015-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional outcome as measured by Constant Shoulder Score and Disabilities of the Arm, Shoulder and Hand (DASH) score', 'timeFrame': '1+ year post-op', 'description': 'The primary outcome measure for this study will be incision related numbness, based on clinical examination and the use of our skin numbness map. Our null hypothesis is that there will be no difference in incision related numbness between the two groups: percutaneous versus open approach. Our primary objective is to disprove this hypothesis, predicting that the percutaneously treated group will have less incisional numbness.'}], 'secondaryOutcomes': [{'measure': 'Incision numbness at surgical site.', 'timeFrame': '2 wks, 6 wks, 3 mths, 6mnths and 1+ year post-op', 'description': 'Our secondary outcome measures will be union, malunion, and nonunion rates between these two methods, as well as infection rates and functional and satisfaction outcomes based on subjective questioning and the DASH and Constant shoulder score questionnaires. Our null hypothesis for these secondary outcomes is that there will be no difference between the two treatment groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Clavicle Fractures', 'Numbness', 'Percutaneous plate fixation', 'open plate fixation', 'incision related numbness', 'union rates', 'subjective', 'questionnaire based outcomes', 'Diaphyseal'], 'conditions': ['Clavicle Fracture']}, 'descriptionModule': {'briefSummary': "This is a prospective, level II evidence comparison between two cohorts. This study is designed to compare the percutaneous versus open approach for plate fixation of diaphyseal clavicle fractures. This study includes questionnaires and measurements that will collect data on incision-related numbness, union rates, overall outcomes, complication rates of the two methods, infection rates, and overall satisfaction. The surgical procedure, all radiographs and follow-up visits to a minimum of one year are the principle investigators (PI's) standard of care for this injury. Measurements and questionnaires are related to the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated surgically for diaphysial clavicle fracture.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* displaced (i.e., no cortical contact of fracture ends on two xray view) diaphyseal clavicle fracture\n* fracture pattern amenable to plate fixation\n* neurologic injury requiring open reduction\n* open clavicle fracture\n* clavicle nonunion (defined as an absence of radiographic bony union in the presence of neurologic, cosmetic, or functional complaints at six months duration\n* symptomatic malunion (defined as a healed, but shortened or angulated fracture in the presence of neurologic, cosmetic, or functional complaints)\n* clavicle fracture associated with a scapular of humeral fracture (floating shoulder)\n\nExclusion Criteria:\n\n* a nondisplaced or minimally displaced closed, neurovascularly intact clavicle fracture\n* fracture of the medial or lateral end of the clavicle\n* pathological fracture\n* patient is unable to medically tolerate general anesthesia\n* patient is unable to provide informed consent or comply with completing questionnaires'}, 'identificationModule': {'nctId': 'NCT01405703', 'briefTitle': 'Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures', 'orgStudyIdInfo': {'id': '36814'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'percuataneous plate fixation', 'description': 'an approach with three small longitudinal incisions', 'interventionNames': ['Other: xrays']}, {'label': 'open plate fixation', 'description': 'large transverse incision', 'interventionNames': ['Other: xrays']}], 'interventions': [{'name': 'xrays', 'type': 'OTHER', 'description': 'xrays from 2 week postop to 5 year postop', 'armGroupLabels': ['open plate fixation', 'percuataneous plate fixation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Orthopedic Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Erik Kubiak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}, {'name': 'Thomas Christensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Eric Kubiak', 'investigatorAffiliation': 'University of Utah'}}}}