Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT06064318
Status:
COMPLETED
Last Update Posted:
2025-06-04
First Post:
2023-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence and Incidence of Multiple Revisions Following Knee Arthroplasty in Denmark 1998-2021: A Nationwide Population-based Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D024162', 'term': 'Second-Look Surgery'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-12', 'size': 461543, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-09-26T09:26', 'hasProtocol': True}, {'date': '2023-07-28', 'size': 1226416, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-09-26T09:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161384}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2023-09-26', 'studyFirstSubmitQcDate': '2023-09-26', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of major n-grade revisions', 'timeFrame': '23 years', 'description': 'standardized prevalence of major n-grade revisions'}, {'measure': 'Incidence of major n-grade revisions', 'timeFrame': '23 years', 'description': 'standardized incidence of major n-grade revisions'}, {'measure': 'Prevalence of all n-grade revisions', 'timeFrame': '23 years', 'description': 'standardized prevalence of all n-grade revisions'}, {'measure': 'Incidence of all n-grade revisions', 'timeFrame': '23 years', 'description': 'standardized incidence of all n-grade revisions'}], 'secondaryOutcomes': [{'measure': 'Incidence of major and all n-grade revisions stratified by sex and age', 'timeFrame': '23 years', 'description': 'Calculation of incidence for major and for all n-grade revisions stratified by sex and by age (groups, sex: male/female, age: 18-49/50-69/70-99)'}, {'measure': 'Prevalence of major and all n-grade revisions stratified by sex and age', 'timeFrame': '23 years', 'description': 'Calculation of prevalence for major and for all n-grade revisions stratified by sex and by age (groups, sex: male/female, age: 18-49/50-69/70-99)'}, {'measure': 'Prevalence of major and all n-grade revisions for patients with their total sum of revisions', 'timeFrame': '23 Years', 'description': 'Calculation of standardized prevalence for patients receiving major or all type of n-grade revision, where the ordering of revisions are not knee specific but patient-specific'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Replacement', 'Knee Replacement Revision']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the incidence and prevalence rates of multiply revised knee arthroplasty patients in Denmark from 1998-2021.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All Danish residents who received a primary knee arthroplasty in Denmark between 1998-2021.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Danish Resident\n* all ages\n* must have had primary knee arthroplasty procedure performed in Denmark between 1998-2021\n\nExclusion Criteria:\n\n* Missing key variables (patient ID, date of surgery, procedure-code, laterality of procedure)\n* Duplicates\n* Non-relevant procedures'}, 'identificationModule': {'nctId': 'NCT06064318', 'acronym': 'EMKAR ONE', 'briefTitle': 'Prevalence and Incidence of Multiple Revisions Following Knee Arthroplasty in Denmark 1998-2021: A Nationwide Population-based Study', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Prevalence and Incidence of Multiple Revisions Following Knee Arthroplasty in Denmark 1998-2021: A Nationwide Population-based Study', 'orgStudyIdInfo': {'id': '08062023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary cohort', 'description': 'All patients with a primary knee arthroplasty performed in Denmark between Jan 1st 1998 and 31st December 2021.'}, {'label': 'Revision cohort', 'description': 'All patients with a revision knee arthroplasty performed in Denmark between Jan 1st 1998 and 31st December 2021', 'interventionNames': ['Procedure: Revision']}], 'interventions': [{'name': 'Revision', 'type': 'PROCEDURE', 'description': 'Any type of knee revision, excluding knee arthrodesis and femur amputation', 'armGroupLabels': ['Revision cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Sharing IPD is not available as the data is protected by GDPR regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Odense University Hospital', 'class': 'OTHER'}, {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Julius Tetens Hald', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}