Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-02-25 @ 5:33 PM
Study NCT ID:
NCT02960633
Status:
UNKNOWN
Last Update Posted:
2016-11-11
First Post:
2016-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Corail Prosthesis With or Without Collar Design
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'lastUpdateSubmitDate': '2016-11-10', 'studyFirstSubmitDate': '2016-11-03', 'studyFirstSubmitQcDate': '2016-11-08', 'lastUpdatePostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The investigators will measure radiolucent lines on X-ray.', 'timeFrame': '5 year', 'description': 'Hypothesis: Collar shows more radiolucent lines on xray in Gruen zone 7.'}]}, 'conditionsModule': {'conditions': ['Coxarthritis']}, 'descriptionModule': {'briefSummary': 'Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Corail prosthesis with or without collar design. Randomized study design focusing on radiolucent lines on standard x-ray.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary THA\n\nExclusion Criteria:\n\n* fractured hips'}, 'identificationModule': {'nctId': 'NCT02960633', 'briefTitle': 'Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Corail Prosthesis With or Without Collar Design', 'organization': {'class': 'OTHER', 'fullName': 'ZOL'}, 'officialTitle': 'Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Corail Prosthesis With or Without Collar Design', 'orgStudyIdInfo': {'id': '16/073U'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'THA with Collar', 'description': 'THA with Collar', 'interventionNames': ['Device: Corail with collar.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'THA without Collar', 'description': 'THA without Collar', 'interventionNames': ['Device: Corail without collar.']}], 'interventions': [{'name': 'Corail with collar.', 'type': 'DEVICE', 'armGroupLabels': ['THA with Collar']}, {'name': 'Corail without collar.', 'type': 'DEVICE', 'armGroupLabels': ['THA without Collar']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ZOL', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident orthopedic Surgery', 'investigatorFullName': 'Jens Vanbiervliet', 'investigatorAffiliation': 'ZOL'}}}}