Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-02-18 @ 6:06 PM
Study NCT ID:
NCT03694457
Status:
UNKNOWN
Last Update Posted:
2022-03-15
First Post:
2018-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'no masking'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-14', 'studyFirstSubmitDate': '2018-10-01', 'studyFirstSubmitQcDate': '2018-10-01', 'lastUpdatePostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Constant Murley Score', 'timeFrame': '12 months', 'description': 'Constant Murley Score it a clinical method of functional assessment of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score'}], 'secondaryOutcomes': [{'measure': 'Quick dash score', 'timeFrame': '3, 6 and 12 months', 'description': 'the Quick Dash score is a functional assessment of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score'}, {'measure': 'SF12 score', 'timeFrame': '3, 6 and 12 months', 'description': 'The SF12 score is a quality of life assessment. The score varies between 0 and 100, more the value is better brought up is the score'}, {'measure': 'Alder score', 'timeFrame': '3, 6 and 12 months', 'description': 'Assessment of external rotation of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score'}, {'measure': 'The Simple Shoulder Test (SST)', 'timeFrame': '3, 6 and 12 months', 'description': 'The Simple Shoulder Test is functional assessment of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score'}, {'measure': 'WOOS (The Western Ontario Osteosarthritis )', 'timeFrame': '3, 6 and 12 months', 'description': 'The Western Ontario Osteosarthritis of the shoulder index is a quality of life measurement tool for osteoarthritis of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score'}, {'measure': 'intensity of pain', 'timeFrame': 'pre op, 3, 6 and 12 months', 'description': 'THE VISUAL SIMILAR SCALE is auto-completed. For the intensity of pain, the scale varies between " no pain " (the score of 0) and " the pain so badly as he could be " or " the worst conceivable pain " (the score of 10)'}, {'measure': 'Radiologic evaluation', 'timeFrame': 'pre op, 3, 6 and 12 months', 'description': 'Radiologic evaluation'}, {'measure': 'Complications', 'timeFrame': 'pre op, 3, 6 and 12 months', 'description': 'list of the complications'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prospective', 'Randomized study', 'Proximal humerus fracture', 'Surgical treatment'], 'conditions': ['Humeral Fracture', 'Aged Patient', 'Reversed Total Shoulder Arthroplasty', 'Surgical Approach']}, '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 aim of the study consists in comparing two surgical approaches (deltopectoral versus lateral deltoid splitting) in the treatment of proximal humerus fractures treated with a reversed total shoulder arthroplasty The assessment will focus on clinical (clinical scores, efficacy, safety…) and radiological results, between these two types of surgical approaches by using a prospective, randomized analysis.', 'detailedDescription': 'The 2 main surgical approaches in total shoulder arthroplasty (TSA) are the anterior approach (deltopectoral) and the lateral one (deltoid splitting) (18).\n\nTheir advantages and drawbacks have not been clearly evaluated in proximal humerus fracture treated with an arthroplasty.\n\nThe goal of the study is to compare the results between patients (older than 65yo) presenting a proximal humerus fracture treated with a reversed shoulder arthroplasty performed through an anterior approach or a lateral one.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient older than 65yo with a proximal humerus fracture (Neer 3-4 and 2 dislcated)\n* Patient registered to the national health system\n* Patient able to understand information about the protocol and answer to questionnaire\n\nExclusion Criteria:\n\n* Non-displaced fracture or no need of surgical treatment.\n* Existing bone disease\n* Infection\n* Neurological deficit (axillary nerve)\n* Multi-injured patients\n* Patient no able to fulfill the questionnaire\n* Patient refuses the study'}, 'identificationModule': {'nctId': 'NCT03694457', 'acronym': 'DELTOSUPEX', 'briefTitle': 'Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture', 'orgStudyIdInfo': {'id': 'CHU-410'}, 'secondaryIdInfos': [{'id': '2018-A02113-52', 'type': 'OTHER', 'domain': '2018-A02113-52'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'deltopectoral approach', 'description': 'the patients are treated with deltopectoral approach surgery', 'interventionNames': ['Procedure: Reversed total shoulder arthroplasty']}, {'type': 'OTHER', 'label': 'lateral approach', 'description': 'the patients are treated with a lateral approach surgery', 'interventionNames': ['Procedure: lateral approach']}], 'interventions': [{'name': 'Reversed total shoulder arthroplasty', 'type': 'PROCEDURE', 'description': 'Replacement of the proximal humeral head by a reversed prosthesis through an anterior approach', 'armGroupLabels': ['deltopectoral approach']}, {'name': 'lateral approach', 'type': 'PROCEDURE', 'description': 'Replacement of the proximal humeral head by a reversed prosthesis through a lateral approach', 'armGroupLabels': ['lateral approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lise LACLAUTRE', 'role': 'CONTACT', 'email': 'drci@chu-clermontferrand.fr', 'phone': '04 73 75 49 63'}, {'name': 'Guillaume VILLATTE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chu Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Lise LACLAUTRE', 'role': 'CONTACT', 'email': 'drci@chu-clermontferrand.fr', 'phone': '04 73 75 49 63'}], 'overallOfficials': [{'name': 'Guillaume VILLATTE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}