Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-03-10 @ 1:09 AM
Study NCT ID:
NCT00603395
Status:
COMPLETED
Last Update Posted:
2014-05-16
First Post:
2007-12-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Clinical Study On A Total Hip Resurfacing System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D010020', 'term': 'Osteonecrosis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 298}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-15', 'studyFirstSubmitDate': '2007-12-23', 'studyFirstSubmitQcDate': '2008-01-16', 'lastUpdatePostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Harris Hip Score, Device Revision/Removal, Radiographic Evaluation', 'timeFrame': '2 years postoperative'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'Anytime'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arthritis', 'Avascular Necrosis']}, 'referencesModule': {'references': [{'pmid': '23234268', 'type': 'DERIVED', 'citation': 'van der Weegen W, Hoekstra HJ, Sijbesma T, Austen S, Poolman RW. Hip resurfacing in a district general hospital: 6-year clinical results using the ReCap hip resurfacing system. BMC Musculoskelet Disord. 2012 Dec 13;13:247. doi: 10.1186/1471-2474-13-247.'}]}, 'descriptionModule': {'briefSummary': 'This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* intended for skeletally mature individuals undergoing primary surgery as a result of hip degenerative joint disease, or any composite diagnoses, including:\n\n * Osteoarthritis\n * Avascular necrosis\n * Traumatic arthritis\n * Legg Perthes\n * Rheumatoid arthritis'}, 'identificationModule': {'nctId': 'NCT00603395', 'briefTitle': 'A Prospective Clinical Study On A Total Hip Resurfacing System', 'organization': {'class': 'OTHER', 'fullName': 'St. Anna Ziekenhuis, Geldrop, Netherlands'}, 'officialTitle': 'A Prospective Clinical Study On A Total Hip Resurfacing System', 'orgStudyIdInfo': {'id': 'EU-6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ReCap', 'description': 'ReCap Total Hip Resurfacing System', 'interventionNames': ['Device: ReCap Total Hip Resurfacing System']}], 'interventions': [{'name': 'ReCap Total Hip Resurfacing System', 'type': 'DEVICE', 'description': 'This is a hip resurfacing system.', 'armGroupLabels': ['ReCap']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Geldrop', 'country': 'Netherlands', 'facility': 'Knowledge Center for Orthopedic Surgery, St. Anna hospital', 'geoPoint': {'lat': 51.42167, 'lon': 5.55972}}], 'overallOfficials': [{'name': 'H J Hoekstra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Anna hospital, Geldrop'}, {'name': 'T Sybesma, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Anna hospital, Geldrop'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Anna Ziekenhuis, Geldrop, Netherlands', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Walter van der Weegen', 'investigatorAffiliation': 'St. Anna Ziekenhuis, Geldrop, Netherlands'}}}}