Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-11 @ 1:03 AM
Study NCT ID:
NCT03379935
Status:
COMPLETED
Last Update Posted:
2017-12-20
First Post:
2017-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radial Head Arthroplasty A Clinical and Radiological Comparison of Monopolar and Bipolar Radial Head Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092467', 'term': 'Radial Head and Neck Fractures'}, {'id': 'D000092482', 'term': 'Elbow Fractures'}], 'ancestors': [{'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D011885', 'term': 'Radius Fractures'}, {'id': 'D005543', 'term': 'Forearm Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-17', 'studyFirstSubmitDate': '2017-12-04', 'studyFirstSubmitQcDate': '2017-12-17', 'lastUpdatePostDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QuickDASH', 'timeFrame': '2-16 years postoperatively', 'description': 'Patients reported outcome measure. An abbreviated version of the Disabilities the Arm, Shoulder and Hand (DASH) questionnaire. Higher score indicate a greater level of disability, lower scores indicate a lower level of disability. The score ranges from 0 (no disability) to 100 (most severe disability).'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': '2-16 years postoperatively', 'description': 'Visual analogue scale. Range 0-10. Higher value indicate more intensive pain.'}, {'measure': 'Range of motion', 'timeFrame': '2-16 years postoperatively', 'description': 'Rang of elbow motion. Measured in grades. Supination, pronation, extension and flexion were measured.'}, {'measure': 'Reoperation', 'timeFrame': '2-16 years postoperatively', 'description': 'Number of patients needing revision surgery'}, {'measure': 'Radiographic evaluation', 'timeFrame': '2-16 years postoperatively', 'description': 'Radiographic evaluation of the prosthesis. The presence of radiolucent lines, loosening of the prosthesis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Radial Head Fracture', 'Elbow Fracture', 'Arthroplasty Complications']}, 'referencesModule': {'references': [{'pmid': '27792673', 'type': 'BACKGROUND', 'citation': 'Heijink A, Kodde IF, Mulder PGH, Veltman ES, Kaas L, van den Bekerom MPJ, Eygendaal D. Radial Head Arthroplasty: A Systematic Review. JBJS Rev. 2016 Oct 18;4(10):e3. doi: 10.2106/JBJS.RVW.15.00095.'}, {'pmid': '27521138', 'type': 'BACKGROUND', 'citation': 'Heijink A, Kodde IF, Mulder PGH, Van Dijk CN, Eygendaal D. Cemented bipolar radial head arthroplasty: midterm follow-up results. J Shoulder Elbow Surg. 2016 Nov;25(11):1829-1838. doi: 10.1016/j.jse.2016.05.017. Epub 2016 Aug 9.'}, {'pmid': '24549774', 'type': 'BACKGROUND', 'citation': 'Duckworth AD, Wickramasinghe NR, Clement ND, Court-Brown CM, McQueen MM. Radial head replacement for acute complex fractures: what are the rate and risks factors for revision or removal? Clin Orthop Relat Res. 2014 Jul;472(7):2136-43. doi: 10.1007/s11999-014-3516-y.'}]}, 'descriptionModule': {'briefSummary': 'Fractures of the radial head are among the most common fractures in the elbow and represent one-third of all elbow fractures.This retrospective cohort study was performed between 2004 and 2014 at Sundsvall and Umeå University hospital, Sweden. All patients who were operated on between 2004 and 2014 with a radial head arthroplasty for an acute or sequelae due to a caput radii fracture.The aim of this study is to evaluate clinical or radiological differences between patients treated with a unipolar or bipolar radial head arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients treated with a radial head arthroplasty are included in the study. All patients were asked to participate in the follow-up during 2017.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients treated with a radial head arthroplasty during the study period.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03379935', 'acronym': 'RHA', 'briefTitle': 'Radial Head Arthroplasty A Clinical and Radiological Comparison of Monopolar and Bipolar Radial Head Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Sundsvall Hospital'}, 'officialTitle': 'Radial Head Arthroplasty: A Clinical and Radiological Comparison of Monopolar and Bipolar Radial Head Arthroplasty', 'orgStudyIdInfo': {'id': 'Radial head arthrplasty'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bipolar radial head arthroplasty', 'description': 'Patients treated with bipolar head arthroplasty due to radial head fracture', 'interventionNames': ['Procedure: Type of radial head arthroplasty']}, {'label': 'Unipolar radial head arthroplasty', 'description': 'Patients treated with unipolar head arthroplasty due to radial head fracture', 'interventionNames': ['Procedure: Type of radial head arthroplasty']}], 'interventions': [{'name': 'Type of radial head arthroplasty', 'type': 'PROCEDURE', 'description': 'Patiens are either treated with a unipolar or a bipolar radial head arthroplasty. At Sundsvall hospital all patients were treated with a unipolar and at Umeå university hospital all patients were treated with a bipolar arthroplasty.', 'armGroupLabels': ['Bipolar radial head arthroplasty', 'Unipolar radial head arthroplasty']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bakir Kadum, M.D, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Umeå University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Researchers are welcome to ask for data. The corresponding author will provide this.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sundsvall Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}