Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 10:20 PM
Study NCT ID:
NCT04637958
Status:
COMPLETED
Last Update Posted:
2020-11-20
First Post:
2020-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Correlation Between Femoral Head and Cup Size and Postoperative Pain in Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 463}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-16', 'studyFirstSubmitDate': '2020-11-16', 'studyFirstSubmitQcDate': '2020-11-16', 'lastUpdatePostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between femoral head and cup size and postoperative pain in Total Hip arthroplasty', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Femoral Head Size', 'Cup Size THP', 'Postoperatie Groin Pain']}, 'referencesModule': {'references': [{'pmid': '23927907', 'type': 'BACKGROUND', 'citation': 'Odri GA, Padiolleau GB, Gouin FT. Oversized cups as a major risk factor of postoperative pain after total hip arthroplasty. J Arthroplasty. 2014 Apr;29(4):753-6. doi: 10.1016/j.arth.2013.07.001. Epub 2013 Aug 6.'}]}, 'descriptionModule': {'briefSummary': 'We want to investigate the correlation between the native femoral head and the implanted cup in Total hip arthroplasty. As second parameter to investigate we believe an oversized cup will cause groin pain. We want to find a cutoff value to predict groin pain after cup implementation in THA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'retrospective database THA', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all primary THA\n\nExclusion Criteria:\n\n* DDH-LCP\n* Acetabulum/femoral neck fracture'}, 'identificationModule': {'nctId': 'NCT04637958', 'acronym': 'jantje', 'briefTitle': 'Correlation Between Femoral Head and Cup Size and Postoperative Pain in Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Correlation Between Femoral Head and Cup Size and Postoperative Pain in Total Hip Arthroplasty', 'orgStudyIdInfo': {'id': 'JBFemHeadTHP'}, 'secondaryIdInfos': [{'id': 'UZ Leuven', 'type': 'OTHER', 'domain': 'UZ Leuven'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'pain', 'description': 'THA', 'interventionNames': ['Device: THA']}, {'label': 'no pain', 'description': 'THA', 'interventionNames': ['Device: THA']}], 'interventions': [{'name': 'THA', 'type': 'DEVICE', 'description': 'Total hip arthroplasty', 'armGroupLabels': ['no pain', 'pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research', 'investigatorFullName': 'Research Orthopedie', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}