Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-20 @ 4:05 PM
Study NCT ID:
NCT00872066
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2009-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Long-term Performance of SmartSet® HV and SmartSet® GHV Bone Cements in Primary Total Hip Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D006618', 'term': 'Hip Dislocation, Congenital'}, {'id': 'D060048', 'term': 'Slipped Capital Femoral Epiphyses'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000082602', 'term': 'Developmental Dysplasia of the Hip'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010009', 'term': 'Osteochondrodysplasias'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D004839', 'term': 'Epiphyses, Slipped'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 243}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-02', 'studyFirstSubmitDate': '2009-03-19', 'studyFirstSubmitQcDate': '2009-03-30', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kaplan-Meier survivorship', 'timeFrame': 'Annually'}], 'secondaryOutcomes': [{'measure': 'Harris Hip Score', 'timeFrame': 'Annually'}, {'measure': 'Oxford Hip Score', 'timeFrame': 'Annually'}, {'measure': 'Radiological Analysis', 'timeFrame': 'Annually'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hip', 'Bone Cement'], 'conditions': ['Rheumatoid Arthritis', 'Osteoarthritis', 'Post-traumatic Arthritis', 'Collagen Disorders', 'Avascular Necrosis', 'Traumatic Femoral Fractures', 'Nonunion of Femoral Fractures', 'Congenital Hip Dysplasia', 'Slipped Capital Femoral Epiphysis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to monitor the performance of artificial hip joints implanted with two different bone cements, SmartSet® HV and SmartSet® GHV, in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to SmartSet® HV or SmartSet® GHV and will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\ni) Male or female subjects, aged between 18 and 75 years (inclusive).\n\nii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.\n\niii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.\n\niv) Subjects requiring primary total hip arthroplasty and are considered suitable for a cemented femoral component.\n\nExclusion Criteria:\n\ni) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.\n\nii) Women who are pregnant.\n\niii) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.\n\niv) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).\n\nv) Subjects who are currently involved in any injury litigation claims.\n\nvi) Subjects with contraindications normally applicable to the use of conventional bone cement, in accordance with the manufacturer's Instructions For Use."}, 'identificationModule': {'nctId': 'NCT00872066', 'briefTitle': 'A Study to Assess the Long-term Performance of SmartSet® HV and SmartSet® GHV Bone Cements in Primary Total Hip Replacement', 'organization': {'class': 'INDUSTRY', 'fullName': 'DePuy International'}, 'officialTitle': 'A Prospective, Randomised, Uncontrolled, Single-Centre, Post-Market Surveillance Study To Evaluate The Performance Of SmartSet® HV and SmartSet® GHV Bone Cements In Primary Cemented Total Hip Arthroplasty(THA)', 'orgStudyIdInfo': {'id': 'CT02/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1) SmartSet® HV Bone Cement', 'description': 'A high viscosity bone cement for use in total hip replacement (without gentamicin)', 'interventionNames': ['Device: SmartSet® HV bone cement']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2) SmartSet® GHV Bone Cement', 'description': 'A high viscosity bone cement for use in total hip replacement (with gentamicin)', 'interventionNames': ['Device: SmartSet® GHV bone cement']}], 'interventions': [{'name': 'SmartSet® HV bone cement', 'type': 'DEVICE', 'description': 'A high viscosity bone cement for use in total hip replacement (without gentamicin)', 'armGroupLabels': ['1) SmartSet® HV Bone Cement']}, {'name': 'SmartSet® GHV bone cement', 'type': 'DEVICE', 'description': 'A high viscosity bone cement for use in total hip replacement (with gentamicin)', 'armGroupLabels': ['2) SmartSet® GHV Bone Cement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Martin', 'country': 'Slovakia', 'facility': 'Orthopaedic-traumatology Clinic University Hospital Martin', 'geoPoint': {'lat': 49.06651, 'lon': 18.92399}}], 'overallOfficials': [{'name': 'Libor Nečas, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopaedic-truamatology Clinic, University Hospital Martin, Slovakia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DePuy International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}