Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-02-23 @ 3:00 AM
Study NCT ID:
NCT02944058
Status:
UNKNOWN
Last Update Posted:
2023-08-15
First Post:
2016-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plate Fixation Versus Intramedullary Nailing of 3 and 4 Part Proximal Humerus 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-10-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-14', 'studyFirstSubmitDate': '2016-10-17', 'studyFirstSubmitQcDate': '2016-10-23', 'lastUpdatePostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-10-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Disabilities of the Arm, Shoulder and Hand (DASH) Score (questionnaire) Disability of the arm, shoulder and arm score (DASH score)', 'timeFrame': '5 years', 'description': 'Quick Dash (questionnaire) the first 6 weeks after surgery, then DASH score (questionnaire for patients to fill out) in follow ups'}], 'secondaryOutcomes': [{'measure': 'Constant score (questionnaire)', 'timeFrame': '5years', 'description': 'A questionnaire for the doctor or the physiotherapist to fill out, including registration of: Pain, Power, Range of motion and ADL (x/100, where 100 is best score)'}, {'measure': 'Radiological complications', 'timeFrame': '5 years', 'description': 'Plate cutout, Nail migration, screw cutout, Reduction of Head shaft angle (HSA)/ Varus subsidence,'}, {'measure': 'Complications', 'timeFrame': '5 years', 'description': 'Infection, Avascular necrosis, thrombosis, nerve compression or damage, Pseudoarthrosis'}, {'measure': 'Health economy', 'timeFrame': '5 years', 'description': 'Registration of visits to doctor, physiotherapist, sick leave, re-operations'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multiloc', 'Philos', 'Locking plate', 'Straight nail', 'Randomized controlled trial', '3 and 4 part fractures'], 'conditions': ['Shoulder Fractures', 'Humeral Fractures, Proximal']}, 'referencesModule': {'references': [{'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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the project is to compare the management of 3 and 4 part proximal humerus fractures (PHF) with an angular stable plate (Philos) with that of an intramedullary nail (Multiloc) in light of complications, radiological, economical, functional and clinical outcome.', 'detailedDescription': 'Randomized controlled trial (RCT) from Akershus University Hospital in Norway. Randomization between two implants. The investigators will use deltopectoral or deltoid split as surgical access. All patients will have calcar screws and cuff sutures. When lack of bone for example after decompressing valgus compressed fractures, a bone-substitute might be used in the surgeons preference. Follow up in outpatient clinic at 6, 12, 52 and 104 weeks, but also a 5 year follow up is planned. Postoperative radiographs of both shoulders and CT of operated shoulder will be taken.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients \\> 18 years\n2. Severe displacement, defined as malposition of at least 45⁰ of angular deviation in valgus or 30⁰ in varus in true frontal projection, regardless of whether the fracture is impacted or not. Fractures with more than 50% displacement of the head against the surgical neck\n3. The greater or lesser tubercles must be fractured in a 3 or 4-part fracture. The degree of displacement is not critical for inclusion.\n\nExclusion Criteria:\n\nExclusion criteria:\n\n1. Fracture more than 3 weeks' old\n2. Caput humeri just a thin shell or split\n3. Ipsilateral damage that will influence the recovery and scoring systems\n4. Incapability to protect osteosynthesis, i.e. use of crutches because of injury to lower extremity.\n5. Pathological fracture\n6. Neurovascular injury\n7. Open fracture\n8. Noncompliance\n9. Congenital anomaly\n10. Ongoing infectious process around the incision site for plate osteosynthesis\n11. Systemic disease that may influence healing processes or scoring systems (RA/MS)\n12. Fracture dislocation\n13. Substance abuse\n14. Inability to read and understand Norwegian\n15. Patients not residing in our catchment area\n16. Patients with too small humerus diameter to use a nail\n17. Patient not able to commit and understand written consent"}, 'identificationModule': {'nctId': 'NCT02944058', 'briefTitle': 'Plate Fixation Versus Intramedullary Nailing of 3 and 4 Part Proximal Humerus Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Akershus'}, 'officialTitle': 'Plate Fixation Versus Intramedullary Nailing of 3 and 4 Part Proximal Humerus Fractures. A RCT', 'orgStudyIdInfo': {'id': '2016/626'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Philos plate', 'description': 'Intervention is surgery with Philos plate', 'interventionNames': ['Procedure: Philos plate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Multiloc nail', 'description': 'Intervention is surgery with Multiloc nail', 'interventionNames': ['Procedure: Multiloc nail']}], 'interventions': [{'name': 'Multiloc nail', 'type': 'PROCEDURE', 'description': 'Intervention is surgery with Multiloc nail', 'armGroupLabels': ['Multiloc nail']}, {'name': 'Philos plate', 'type': 'PROCEDURE', 'description': 'Intervention is surgery with Philos plate', 'armGroupLabels': ['Philos plate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1478', 'city': 'Lørenskog', 'country': 'Norway', 'facility': 'Akershus University hospital'}], 'overallOfficials': [{'name': 'Asbjorn AAroen, PhD MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Akershus University Hospital, orthopedic unit'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Akershus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Asbjorn Aroen', 'investigatorAffiliation': 'University Hospital, Akershus'}}}}