Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2026-01-01 @ 12:00 PM
Study NCT ID:
NCT00205959
Status:
COMPLETED
Last Update Posted:
2020-08-14
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LPHP-Philos-PHN Conservative Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012784', 'term': 'Shoulder Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 640}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2006-08'}, 'lastUpdateSubmitDate': '2020-08-12', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiological comparison of the fracture healing'}, {'measure': 'Functional outcome based on "constant and neer score" after 12 months'}], 'secondaryOutcomes': [{'measure': 'Analysis of occured complications'}, {'measure': 'Radiological evaluation of possible misallocation'}, {'measure': 'Subjective patient judgement of before and after treatment according to DASH-questionnaire'}]}, 'conditionsModule': {'keywords': ['Humerus', 'Fractures', 'Locking Plates', 'Nail System'], 'conditions': ['Proximal Humeral Fracture']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the results regarding fracture healing\n\nand functional outcome after the treatment of proximal humeral fractures\n\nwith the four different treatment methods after 12w./6months and 12 months\n\nbased on radiological evaluation as well as the "constant score" and the\n\n"neer score".', 'detailedDescription': 'Evaluation of proximal humeral fractures using a new stable-angled implant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* fractures of proximal humerus\n* age over 18 years\n* completed skeletal development\n* fracture less than 5 days old\n\nExclusion Criteria:\n\n* open fractures\n* pseudoarthrosis, pathological or refractures\n* ipsilateral fractures of distal humerus or elbow\n* polytraumatic conditions\n* pregnancy\n* subject with known history of diseases that influence the healing process\n* alcohol, drug abuse'}, 'identificationModule': {'nctId': 'NCT00205959', 'briefTitle': 'LPHP-Philos-PHN Conservative Treatment', 'organization': {'class': 'OTHER', 'fullName': 'AO Innovation Translation Center'}, 'officialTitle': 'Comparison of Standard Treatment Methods for Proximal Humerus Fractures', 'orgStudyIdInfo': {'id': '02-LPP-04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Locking proximal humerus plate', 'type': 'DEVICE'}, {'name': 'Proximal Humerus Internal Locking System', 'type': 'DEVICE'}, {'name': 'Proximal Humerus Nail', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Universitaestklinik Freiburg, Klinik für Traumatologie', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}], 'overallOfficials': [{'name': 'Norbert Südkamp, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaetsklinik Freiburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AO Clinical Investigation and Publishing Documentation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Synthes Inc.', 'class': 'INDUSTRY'}, {'name': 'AO Research Fund', 'class': 'OTHER'}]}}}