Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-02-26 @ 6:28 AM
Study NCT ID:
NCT01984112
Status:
COMPLETED
Last Update Posted:
2015-10-05
First Post:
2013-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proximal Humerus Fractures: Randomized Study Between Locking Nails and Locking Plates for Neer 2 and 3 Parts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012784', 'term': 'Shoulder Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D006810', 'term': 'Humeral Fractures'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}], 'ancestors': [{'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': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-02', 'studyFirstSubmitDate': '2013-10-28', 'studyFirstSubmitQcDate': '2013-11-07', 'lastUpdatePostDateStruct': {'date': '2015-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Post-operative integrity of the rotator cuff, evaluated by ultrasonography', 'timeFrame': '6 months', 'description': 'Post-operative integrity of the rotator cuff, evaluated by ultrasonography'}], 'primaryOutcomes': [{'measure': 'Shoulder function, pain, strength and range of motion, measured by Constant-Murley Score', 'timeFrame': '12 months', 'description': 'Absolute Constant-Murley Score, that measures:\n\nShoulder function, pain, strength and range of motion 0-100 points score 12 months as the final outcome'}], 'secondaryOutcomes': [{'measure': 'Superior limb function, measured by DASH score', 'timeFrame': '12 months', 'description': 'Disability of Arm-Shoulder-Hand score'}, {'measure': 'Shoulder function, pain, strength, range of motion and satisfaction with treatment, measured by UCLA score', 'timeFrame': '12 months', 'description': 'Shoulder function, pain, strength, range of motion and satisfaction with treatment, measured by University of California Los Angeles score.\n\n0-35 points score'}, {'measure': 'Shoulder function, pain, strength and range of motion compared with non-injuried shoulder, measured by Individual Relative Constant-Murley Score', 'timeFrame': '12 months', 'description': 'Individual Relative Constant-Murley Score, compared to non-injured shoulder.\n\nFialka C, Oberleitner G, Stampfl P, Brannath W, Hexel M, Vécsei V. Modification of the Constant-Murley shoulder score-introduction of the individual relative Constant score Individual shoulder assessment. Injury. 2005 Oct;36(10):1159-65.'}, {'measure': 'Number of patients with complications', 'timeFrame': '12 months', 'description': 'Overall complications and need for additional surgery, categorized as:\n\nNot related to implant\n\nClinical\n\n* Death in the intraoperative or postoperative period;\n* Clinical complications related to surgery .\n\nOrthopedic\n\n* Infection\n* Osteonecrosis ;\n* Nonunion ;\n* Stiffness\n* Reflex sympathetic dystrophy ;\n* Heterotopic ossification ;\n* Refracture ;\n* Neurological injury .\n* Insufficient reduction;\n* Loss of reduction of the humeral head;\n* Loss of reduction of tubercule: deviation greater than 5 mm between the immediate postoperative radiographs and 12 months;\n\nRelated to the implant\n\n* Primary articular protrusion of screws;\n* Loosening of the implant ;\n* Breaking of the implant ;\n* Cutout: loss reduction head with proximal screw pullout ;\n* secondary articular protrusion screws;\n* Malunion\n* Injury to the rotator cuff tendons is observed in postoperative ultrasonography;'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Humerus', 'fracture', 'nail', 'plate', 'tuberosity'], 'conditions': ['Humerus', 'Proximal Humeral Fracture', 'Fractures, Bone', 'Humeral Fractures', 'Wounds and Injuries', 'Arm Injuries']}, '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 hypothesis of this study is to determine whether the technique of intramedullary locking nail presents clinical results comparable to the technique of locking plates, based on the Constant Score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fracture with less than 21 days;\n* Fractures of the proximal humerus classified as 2 or 3 parts of Neer, with involvement of the humeral head and one of the tuberosities;\n* Fracture with unacceptable deviation for the non-surgical treatment, according to the criteria of Neer Neer: fractures with deviation greater than 45 ° or 1 cm for the fragment of the humeral head and fractures with a deviation of the tuberosity greater than 0.5 cm;\n* Closed fractures;\n\nExclusion Criteria:\n\n* Characteristics of the fracture:\n\n * fracture between the greater tubercle and the smaller, independent of the deviation;\n * Isolated fracture of the greater or lesser tuberosity\n * 4-part fractures of Neer;\n * Fracture involving the articular surface of the humeral head;\n * Fracture-dislocation of the proximal humerus\n* Other criteria:\n\n * Neurological injuries in the affected limb;\n * previous surgery on the affected shoulder;\n * associated fractures in the affected limb;\n * pathologic fractures;\n * lesions of the rotator cuff tendons previously diagnosed;\n * Psychiatric illnesses or inability to understand preoperative questionnaires;\n * Active infection or previous infection on the shoulder;'}, 'identificationModule': {'nctId': 'NCT01984112', 'briefTitle': 'Proximal Humerus Fractures: Randomized Study Between Locking Nails and Locking Plates for Neer 2 and 3 Parts', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Proximal Humerus Fractures: Randomized Study Between Intramedullary Locking Nails and Locking Plates for Neer 2 and 3 Parts Displaced Fractures', 'orgStudyIdInfo': {'id': '0232/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intramedullary Locked Nail', 'interventionNames': ['Device: Intramedullary locked nail']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Locked Plate', 'interventionNames': ['Device: Locked plate']}], 'interventions': [{'name': 'Locked plate', 'type': 'DEVICE', 'otherNames': ['Philos plaste, Synthes, Switzerland'], 'description': 'Osteosynthesis with philos plate, through deltopectoral approach and rotator cuff augmentation with inabsorbable poliester suture', 'armGroupLabels': ['Locked Plate']}, {'name': 'Intramedullary locked nail', 'type': 'DEVICE', 'otherNames': ['Centronail, Proximal Humeral Nail, Orthofix, Italy'], 'description': 'Intramedullary locked nail performed by antero-lateral transdeltoid minimally invasive approach and rotator cuff augmentation with inabsorbable poliester suture', 'armGroupLabels': ['Intramedullary Locked Nail']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-010', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto de Ortopedia e Traumatologia', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Mauro EC Gracitelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Mauro Gracitelli', 'investigatorAffiliation': 'University of Sao Paulo'}}}}