Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-03-12 @ 6:27 AM
Study NCT ID:
NCT01737060
Status:
COMPLETED
Last Update Posted:
2022-10-04
First Post:
2012-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Displaced Proximal Humeral Fractures: Delta Prothesis or Philos Plate?
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-01', 'studyFirstSubmitDate': '2012-11-20', 'studyFirstSubmitQcDate': '2012-11-26', 'lastUpdatePostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '15D Quality of Life score', 'timeFrame': '5 years', 'description': 'Follow-up will be at 3-6-12 months and 2-5 years.'}, {'measure': 'Health Economics', 'timeFrame': '5 years', 'description': 'Follow-up will be at 3-6-12 months and 2-5 years.'}], 'primaryOutcomes': [{'measure': 'Constant Shoulder Score', 'timeFrame': '5 years', 'description': 'Follow-up will be at 3-6-12 months and 2-5 years.'}], 'secondaryOutcomes': [{'measure': 'Oxford Shoulder score', 'timeFrame': '5 years', 'description': 'Follow-up will be at 3-6-12 months and 2-5 years.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Reversed prosthesis, Philos, Severe displaced'], 'conditions': ['Proximal Humeral Fractures, AO/OTA (2007) Group B2 and C2']}, 'referencesModule': {'references': [{'pmid': '25261913', 'type': 'RESULT', 'citation': 'Fjalestad T, Iversen P, Hole MO, Smedsrud M, Madsen JE. Clinical investigation for displaced proximal humeral fractures in the elderly: a randomized study of two surgical treatments: reverse total prosthetic replacement versus angular stable plate Philos (The DELPHI-trial). BMC Musculoskelet Disord. 2014 Sep 28;15:323. doi: 10.1186/1471-2474-15-323.'}, {'pmid': '31977825', 'type': 'RESULT', 'citation': 'Fraser AN, Bjordal J, Wagle TM, Karlberg AC, Lien OA, Eilertsen L, Mader K, Apold H, Larsen LB, Madsen JE, Fjalestad T. Reverse Shoulder Arthroplasty Is Superior to Plate Fixation at 2 Years for Displaced Proximal Humeral Fractures in the Elderly: A Multicenter Randomized Controlled Trial. J Bone Joint Surg Am. 2020 Mar 18;102(6):477-485. doi: 10.2106/JBJS.19.01071.'}, {'pmid': '35727196', 'type': 'DERIVED', 'citation': 'Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.'}, {'pmid': '35109905', 'type': 'DERIVED', 'citation': 'Bones I, Karlberg AC, Liljeholm M, Fraser AN, Madsen JE, Fjalestad T. Pegs not superior to screws for fixation of fractures of the proximal humerus. J Orthop Surg Res. 2022 Feb 2;17(1):66. doi: 10.1186/s13018-022-02947-3.'}], 'seeAlsoLinks': [{'url': 'https://oslo-universitetssykehus.no/avdelinger/ortopedisk-klinikk/ortopedisk-avdeling-ulleval/seksjon-for-ortopedisk-traumatologi-ulleval/brudd-i-ovre-del-av-overarmsbeinet-proksimale-humerus-delphistudien', 'label': 'Trial website for patients, their relatives and health workers'}]}, 'descriptionModule': {'briefSummary': 'To investigate the assumption that reversed shoulder prosthetic replacement will give a better functional outcome compared to open reduction and internal fixation with an angular stable plate in displaced proximal humeral fractures. Short name: The DelPhi trial.', 'detailedDescription': 'Reversed total shoulder artroplasty (RTSA) equals Delta Xtend reversed total shoulder prosthesis.\n\nAngular stable plate means Proximal humerus plate (Philos)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient admitted in hospital with a displaced three- or four part proximal humerus fracture of OTA / AO group 11-B2 or 11-C2 (displaced fracture of extra-articular or articular, bifocal type). The subgroups -.1, -.2 and -.3 will be included for both B2 and C2 groups, provided severe displacement: This is defined as a mal-position of at least 45º of angular deviation in valgus or 30º in varus in true frontal projection, regardless of whether the fracture is impacted or not, or less than 50% contact between humeral head and the metaphyseal part of the shaft. The greater or lesser tubercle displaced at least 10 mm.\n\nExclusion Criteria:\n\nPatient younger than 65 years or older than 85 years, previous history of injury or illness of the injured shoulder, injuries of other parts of the humerus or the contra-lateral upper extremity, alcohol- or drug abuse, dementia, neurological diseases, or severe cardiovascular or lung diseases that would contraindicate surgery. Patients have to understand the Norwegian language and be compliant to rehabilitation and follow-ups.'}, 'identificationModule': {'nctId': 'NCT01737060', 'acronym': 'DELPHI', 'briefTitle': 'Displaced Proximal Humeral Fractures: Delta Prothesis or Philos Plate?', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Clinical Investigation for Fractures of the Proximal Humerus in Elderly Patients. A Randomized Study of Two Surgical Treatments: Reverse Total Shoulder Arthroplasty Versus Angular Stable Device Philos', 'orgStudyIdInfo': {'id': 'RTSA s422'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Angular stable plate Philos', 'description': 'Open Reduction and Osteofixation with Philos plate and TiCron cerclages', 'interventionNames': ['Device: Reverse total shoulder arthroplasty']}, {'type': 'EXPERIMENTAL', 'label': 'Reverse Total Shoulder Artroplasty', 'description': 'Intervention group', 'interventionNames': ['Device: Reverse total shoulder arthroplasty']}], 'interventions': [{'name': 'Reverse total shoulder arthroplasty', 'type': 'DEVICE', 'otherNames': ['Delta Xtend shoulder proshesis'], 'armGroupLabels': ['Angular stable plate Philos', 'Reverse Total Shoulder Artroplasty']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sykehuset Telemark', 'class': 'OTHER_GOV'}, {'name': 'Sykehuset Asker og Baerum', 'class': 'OTHER'}, {'name': 'Sykehuset Ostfold', 'class': 'OTHER'}, {'name': 'Helse Forde', 'class': 'OTHER'}, {'name': 'Sykehuset i Vestfold HF', 'class': 'OTHER'}, {'name': 'Diakonhjemmet Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD Senior Consultant', 'investigatorFullName': 'Tore Fjalestad', 'investigatorAffiliation': 'Oslo University Hospital'}}}}