Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-01-13 @ 3:43 PM
Study NCT ID:
NCT03637608
Status:
UNKNOWN
Last Update Posted:
2019-05-30
First Post:
2018-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proximal Humerus Fractures: A Retrospective Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012784', 'term': 'Shoulder Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-29', 'studyFirstSubmitDate': '2018-07-24', 'studyFirstSubmitQcDate': '2018-08-14', 'lastUpdatePostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total operative time', 'timeFrame': 'preoperative to up to 8 years postoperative', 'description': 'minutes'}, {'measure': 'amount of blood loss', 'timeFrame': 'preoperative to up to 8 years postoperative', 'description': 'mls'}], 'secondaryOutcomes': [{'measure': 'Patient Outcomes', 'timeFrame': 'preoperative to up to 8 years postoperative', 'description': 'American Shoulder and Elbow Surgeon score to measure shoulder function and pain. Scale of 0-100, 100 being the best possible score'}, {'measure': 'Patient Outcomes', 'timeFrame': 'preoperative to up to 8 years postoperative', 'description': 'Simple Shoulder Test score to measure shoulder function. Scale from 0-12, 12 being the most functional.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Proximal Humeral Fracture']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate preoperative objective measurements of patients with a proximal humerus fracture and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 18 years old or greater at the time of open reduction, internal fixation surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All eligible patients of the principal investigator receiving open reduction internal fixation of the proximal humerus for any indication at St. Elizabeth Healthcare on or after January 1, 2010 will be evaluated and included in the data analysis.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. English speaking\n2. \\>18 years of age\n3. open reduction internal fixation surgical management of a proximal humeral fracture\n\nExclusion Criteria:\n\n1. Non-English speaking\n2. \\<18 years of age\n3. Greater Tuberosity Fractures'}, 'identificationModule': {'nctId': 'NCT03637608', 'acronym': 'PHFx', 'briefTitle': 'Proximal Humerus Fractures: A Retrospective Analysis', 'organization': {'class': 'OTHER', 'fullName': 'The Orthopaedic Research & Innovation Foundation'}, 'officialTitle': 'PROXIMAL HUMERAL FRACTURES: A Data Analysis on Patients Undergoing Open Reduction and Internal Fixation for the Surgical Management of Proximal Humeral Fractures', 'orgStudyIdInfo': {'id': 'ORIF.002'}}, 'contactsLocationsModule': {'locations': [{'zip': '41017', 'city': 'Edgewood', 'state': 'Kentucky', 'country': 'United States', 'facility': 'The Orthopaedic Research & Innovation Foundation', 'geoPoint': {'lat': 39.01867, 'lon': -84.58189}}], 'overallOfficials': [{'name': 'R M Greiwe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Orthopaedic Research & Innovation Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Orthopaedic Research & Innovation Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}