Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT04634305
Status:
UNKNOWN
Last Update Posted:
2021-05-21
First Post:
2020-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical and Functional Results After Total Elbow Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092482', 'term': 'Elbow Fractures'}], 'ancestors': [{'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057929', 'term': 'Arthroplasty, Replacement, Elbow'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'targetDuration': '72 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-20', 'studyFirstSubmitDate': '2020-10-18', 'studyFirstSubmitQcDate': '2020-11-12', 'lastUpdatePostDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mayo Elbow Performance Score', 'timeFrame': 'through study completion, an average of 5 years'}, {'measure': 'QuickDASH', 'timeFrame': 'through study completion, an average of 5 years'}, {'measure': 'Range of motion', 'timeFrame': 'through study completion, an average of 5 years'}], 'secondaryOutcomes': [{'measure': 'Implant loosening', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'Radiolucent lines around the implant on the X Ray'}, {'measure': 'Triceps deficiency', 'timeFrame': 'through study completion, an average of 5 years'}, {'measure': 'Bushing wear', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'Measure of an angle on the X Ray'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Elbow Fracture', 'Elbow Arthropathy', 'Elbow Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Analysis of clinical and functional outcomes after a total elbow arthrosplasty, all indications combined, with a minimum follow up of 24 months The hypothesis is that there a significant improvement after an elbow replacement, no matter what the surgery indication is'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Every patient that underwent a total elbow arthroplasty between january 2004 and august 2020 by a single operator in our orthopedic center', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Total elbow arthroplasty, all indication combined\n\nExclusion Criteria:\n\n* Less than 24 months of follow up\n* Revision of total elbow arthroplasty'}, 'identificationModule': {'nctId': 'NCT04634305', 'briefTitle': 'Clinical and Functional Results After Total Elbow Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Evaluation of the Clinical and Functional Results Obtained After a Total Elbow Arthroplasty, All Indications Combined', 'orgStudyIdInfo': {'id': '2020PI204'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Total elbow arthroplasty', 'description': 'Total elbow arthroplasty, all indications combined', 'interventionNames': ['Procedure: Total elbow arthroplasty']}], 'interventions': [{'name': 'Total elbow arthroplasty', 'type': 'PROCEDURE', 'description': 'Total elbow arthroplasty by a single operator', 'armGroupLabels': ['Total elbow arthroplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'state': 'Lorraine', 'country': 'France', 'facility': 'CHRU Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor François Sirveaux', 'investigatorFullName': 'François SIRVEAUX', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}