Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-03-12 @ 2:25 AM
Study NCT ID:
NCT02566018
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2015-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Proximal Humerus Fractures in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006810', 'term': 'Humeral Fractures'}], 'ancestors': [{'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-13', 'studyFirstSubmitDate': '2015-09-30', 'studyFirstSubmitQcDate': '2015-09-30', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'personal dependency status', 'timeFrame': '6 months', 'description': 'A simple four point rating is used at the time of injury (for the premorbid state) and at 6 months to demonstrate the impact of the injury (including its treatment) on the ability to return to the former social environment and degree of self-dependency.'}], 'secondaryOutcomes': [{'measure': 'range of motion', 'timeFrame': '6 months'}, {'measure': 'Shoulder pain and disability index (SPADI)', 'timeFrame': '6 months', 'description': 'The SPADI is a patient-based questionnaire containing 15 questions about pain and activities of daily living that must be answered by the patient on a scale of 0-10 (0 = no pain / no difficulties to 10 = Worst pain / activity). Five questions relate to the pain and 8 questions relate to the function in daily activities, both subscores are combined and converted to the total score to 0 (= lowest score) to 100 (= best result). A validated German version is available'}, {'measure': 'SSV', 'timeFrame': '6 months', 'description': 'The Subjective Shoulder Value (SSV) is based on a single question that is answered subjectively by the patients. The English formulation of this question is: "What is the overall percent value of your shoulder if a completely normal shoulder represents 100%?" 12 It is an easily administered measure of shoulder function.'}, {'measure': 'General health using EuroQuality of life (EQ)-5D-5L visual analogue scale (VAS)', 'timeFrame': '6 months', 'description': 'The gain in quality of life within two years after surgery is assessed using the generic Quality of Life (QoL) EuroQoL EQ-5D-5L instrument.'}, {'measure': 'Quality of life (utilities) derived using EQ-5D-5L', 'timeFrame': '6 months', 'description': 'Using the EQ-5D-5L instrument patients are asked to report on their general health status on a VAS scale from 0 (worst possible health) to 100 (best possible health).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['elderly'], 'conditions': ['Humeral Fractures']}, 'referencesModule': {'references': [{'pmid': '8970896', 'type': 'RESULT', 'citation': 'Schurch MA, Rizzoli R, Mermillod B, Vasey H, Michel JP, Bonjour JP. A prospective study on socioeconomic aspects of fracture of the proximal femur. J Bone Miner Res. 1996 Dec;11(12):1935-42. doi: 10.1002/jbmr.5650111215.'}, {'pmid': '32057657', 'type': 'RESULT', 'citation': 'Rikli D, Feissli S, Muller AM, Steinitz A, Suhm N, Jakob M, Audige L. High rate of maintaining self-dependence and low complication rate with a new treatment algorithm for proximal humeral fractures in the elderly population. J Shoulder Elbow Surg. 2020 Jun;29(6):1127-1135. doi: 10.1016/j.jse.2019.11.006. Epub 2020 Feb 10.'}]}, 'descriptionModule': {'briefSummary': 'This study is set to evaluate a proposed standard for the treatment of proximal humerus fractures', 'detailedDescription': 'This study investigates the effect of routine treatment algorithm for proximal humerus fractures. All applied treatments are approved and reflect routine practice. The follow-up investigation as planned for this study is associated with only minimal risk for the concerned patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients fulfilling all of the following inclusion criteria', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 65 years or above\n* Proximal humerus fracture\n* Informed consent by the patient or legal representatives to participate in the study\n\nExclusion Criteria:\n\n* More than one fracture, polytrauma\n* Suspicion of a pathological fracture in the context of known or unknown malignancy\n* Previous surgery of the proximal humerus on the same side\n* High energy trauma\n* Open Fracture\n* Insufficient German language skills'}, 'identificationModule': {'nctId': 'NCT02566018', 'acronym': 'prox_hum', 'briefTitle': 'Treatment of Proximal Humerus Fractures in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Treatment Options for Proximal Humerus Fractures in the Elderly and Their Implication on Personal Independence', 'orgStudyIdInfo': {'id': '2014-310'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'experimental intervention', 'description': 'A greater degree of initial displacement is tolerated to allow for conservative, non-operative treatment in more simple fracture patterns. Two-part fractures with marked displacement including two part patterns with a non-displaced greater or minor tuberosity fracture (formally three part fractures) are treated with a proximal humerus nail; and displaced three and four part fractures are primarily managed with a reverse total shoulder arthroplasty. Proximal Humeral Internal Locking System (PHILOS)-plates are only used exceptionally in this group of patients.', 'interventionNames': ['Procedure: treatment/medical device']}, {'label': 'control intervention', 'description': 'Since May 2013 we have changed our treatment algorithm for the treatment of fractures of the humeral head in the elderly. Before this change in algorithm we used PHILOS plates extensively and rarely Inverse Shoulder prostheses.\n\nIn general all proximal humerus fractures were operated except minimally or undisplaced.', 'interventionNames': ['Procedure: standard']}], 'interventions': [{'name': 'treatment/medical device', 'type': 'PROCEDURE', 'description': 'The new treatment algorithm was applied to all patients with proximal humerus fracture as from May 2013 onwards', 'armGroupLabels': ['experimental intervention']}, {'name': 'standard', 'type': 'PROCEDURE', 'description': 'The old treatment algorithm was applied to all patients with proximal humerus fracture up to May 2013.', 'armGroupLabels': ['control intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4021', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Daniel Rikli, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}