Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-01 @ 11:21 AM
Study NCT ID:
NCT02696395
Status:
UNKNOWN
Last Update Posted:
2016-03-02
First Post:
2015-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RSA-measured in Vivo Migration and Micromotion in the DePuy Tri-Lock, Corail and Deltamotion Hip Replacement Components
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-25', 'studyFirstSubmitDate': '2015-11-16', 'studyFirstSubmitQcDate': '2016-02-25', 'lastUpdatePostDateStruct': {'date': '2016-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean total Radio Stereometric Analysis (RSA) measured migration of DePuy Tri-Lock® femoral stem vs DePuy Corail® femoral stem (mm/yr).', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Dynamically Inducible Micromotion (DIMM) of DePuy Corail®, Tri-Lock® and Deltamotion® components (mm/yr).', 'timeFrame': '3 years'}, {'measure': 'Radio Stereometric Analysis (RSA) measured migration of DePuy Deltamotion® acetabular component', 'timeFrame': '3 years'}, {'measure': 'Change in Oxford Hip Score (OHS) at three years.', 'timeFrame': '3 years'}, {'measure': 'Change in bone density using Dual Energy X-Ray Absorptiometry (DEXA) scan at 12 months.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hip Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Hip replacements are being performed on an increasingly active population, who are likely to wear their implants out prematurely. New hip replacements have been devised to minimise the risk of failure. DePuy RSA RCT is a randomised controlled trial designed to compare the performance of two established types of hip replacements using Corail and Tri-Lock stems along with Deltamotion acetabular component. The primary objective of the trial is to compare the long term stability of these two devices.To do this, the study will use an advanced 3D Xray technique to detect migration of the components at 3 years. The study will also measure micromotion of Corail, Tri-Lock and Deltamotion components, patient reported outcome measures and change in bone density.This study is being conducted at a single site, at the Nuffield Orthopaedic Centre, Oxford.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women aged between 18 and 65 years and men aged between 18 and 70 years.\n\n * Participant is willing and able to give informed consent for participation in the study.\n * Diagnosed with hip osteoarthritis.\n * Able (in the Investigators opinion) and willing to comply with all study requirements.\n * Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.\n\nExclusion Criteria:\n\n* Any patients with an inflammatory arthropathy, osteoporosis or deformities of the proximal femur.\n\n * Patients who have significant co-morbidities that would make follow-up difficult or uncomfortable.\n * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study."}, 'identificationModule': {'nctId': 'NCT02696395', 'acronym': 'DePuy RSA RCT', 'briefTitle': 'RSA-measured in Vivo Migration and Micromotion in the DePuy Tri-Lock, Corail and Deltamotion Hip Replacement Components', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'RSA-measured in Vivo Migration and Micromotion in the DePuy Tri-lock, Corail and Deltamotion Hip Replacement Components: a Single-blinded Randomised Control Trial', 'orgStudyIdInfo': {'id': 'DePuy RSA RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DePuy Tri-Lock®', 'description': 'Total hip replacement with DePuy Tri-Lock® femoral stem and Deltamotion® acetabular component. The surgery will be conducted using a postero-lateral approach followed by post operative rehabilitation as per standard care.', 'interventionNames': ['Device: DePuy Tri-Lock® femoral stem + Deltamotion® acetabular component']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DePuy Corail®', 'description': 'Total hip replacement with DePuy Corail® femoral stem and Deltamotion® acetabular component. The surgery will be conducted using a postero-lateral approach followed by post operative rehabilitation as per standard care.', 'interventionNames': ['Device: DePuy Corail® femoral stem + Deltamotion® acetabular component']}], 'interventions': [{'name': 'DePuy Tri-Lock® femoral stem + Deltamotion® acetabular component', 'type': 'DEVICE', 'armGroupLabels': ['DePuy Tri-Lock®']}, {'name': 'DePuy Corail® femoral stem + Deltamotion® acetabular component', 'type': 'DEVICE', 'armGroupLabels': ['DePuy Corail®']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 7HE', 'city': 'Oxford', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Sion Glyn-Jones, MA, DPhil, FRCS', 'role': 'CONTACT', 'email': 'sion.glyn-jones@ndorms.ox.ac.uk', 'phone': '+441865737839'}, {'name': 'John Broomfield, MBChB, MSc, MRCS', 'role': 'CONTACT', 'email': 'john.broomfield@ndorms.ox.ac.uk', 'phone': '+441865223422'}, {'name': 'Sion Glyn-Jones, MA, DPhil, FRCS', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Adrian Taylor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'David Beard', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Duncan Whitwell', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ramy Mansour', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ben Kendrick', 'role': 'SUB_INVESTIGATOR'}, {'name': 'John Broomfield', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Nuffield Orthopaedic Centre', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'collaborators': [{'name': 'DePuy International', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}