Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-28 @ 12:15 AM
Study NCT ID:
NCT06354894
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Percutaneous Pinning Versus Plate and Screws for Surgical Fixation of Proximal Humeral Fractures
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2024-03-18', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxford Shoulder Score (OSS)', 'timeFrame': '1 year', 'description': 'Patient reported outcome. Score from 0 to 48 points (with the higher score being the better)'}, {'measure': 'Quick Disabilities of the arm, shoulder and hand (DASH) score', 'timeFrame': '1 year', 'description': 'The questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms ranging from 0 (no disability) to 100 (most severe disability)'}, {'measure': 'Subjective Shoulder Value (SSV)', 'timeFrame': '1 year', 'description': "The subjective shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder during ADLs (from 0% to 100%, with the higher score being the better)"}, {'measure': 'Radiographic outcomes', 'timeFrame': '1 year', 'description': 'Shoulder x-rays will be reviewed by a panel of experts in shoulder traumatology who will be asked to define the result as:\n\n* normal\n* nonunion\n* malunion\n* avascular necrosis\n* infection'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Proximal Humeral Fractures']}, 'descriptionModule': {'briefSummary': 'The aim of this multicenter nonrandomised study is to prospectively compare the clinical and radiographic results of two different techniques of surgical fixation of proximal humeral fractures: percutaneous pinning versus plate and screws.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients affected by proximal humeral fractures who consent to participate the study and whose fracture was considered to be treated with surgical fixation either with percutaneous pinning or with plate and screws', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 year old\n* proximal humeral fracture\n* both X-rays and CT scan available\n\nExclusion Criteria:\n\n* dementia\n* psychiatric disease'}, 'identificationModule': {'nctId': 'NCT06354894', 'briefTitle': 'Percutaneous Pinning Versus Plate and Screws for Surgical Fixation of Proximal Humeral Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University of Turin, Italy'}, 'officialTitle': "Riduzione e Sintesi Delle Fratture Del Terzo Prossimale d'Omero: Confronto Prospettico Tra Placca e Viti e Pinning Percutaneo", 'orgStudyIdInfo': {'id': 'MACOXS'}, 'secondaryIdInfos': [{'id': '133/2020/U', 'type': 'REGISTRY', 'domain': 'MACOXS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients affected by proximal humeral fracture', 'interventionNames': ['Device: Proximal humeral fracture fixation']}], 'interventions': [{'name': 'Proximal humeral fracture fixation', 'type': 'DEVICE', 'description': 'percutaneous pinning VS plate and screws', 'armGroupLabels': ['Patients affected by proximal humeral fracture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10043', 'city': 'Orbassano', 'state': 'Turin', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Enrico Bellato, MD', 'role': 'CONTACT', 'email': 'enrico.bellato@unito.it', 'phone': '+393406429207'}], 'facility': 'San Luigi Gonzaga Hospital', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}], 'centralContacts': [{'name': 'Enrico Bellato, MD', 'role': 'CONTACT', 'email': 'enrico.bellato@unito.it', 'phone': '+393406429207'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turin, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}