Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-27 @ 8:20 AM
Study NCT ID:
NCT00837850
Status:
COMPLETED
Last Update Posted:
2011-08-26
First Post:
2009-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SmartSet HV and Palacos R RSA Bone Cements in Primary Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-25', 'studyFirstSubmitDate': '2009-02-04', 'studyFirstSubmitQcDate': '2009-02-04', 'lastUpdatePostDateStruct': {'date': '2011-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distal migration of the charnley femoral stem', 'timeFrame': '2010'}], 'secondaryOutcomes': [{'measure': 'Rotational movements of the charnley femoral stem', 'timeFrame': '2010'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['total hip arthroplasty', 'Charnley stem', 'RSA', 'non-inflammatory arthritis'], 'conditions': ['Arthritis']}, 'referencesModule': {'references': [{'pmid': '20198403', 'type': 'RESULT', 'citation': 'Husby OS, Haugan K, Benum P, Foss OA. A prospective randomised radiostereometric analysis trial of SmartSet HV and Palacos R bone cements in primary total hip arthroplasty. J Orthop Traumatol. 2010 Mar;11(1):29-35. doi: 10.1007/s10195-010-0087-x. Epub 2010 Mar 3.'}]}, 'descriptionModule': {'briefSummary': 'A randomised radiostereometric study comparing SmartSet HV and Palacos R acrylic bone cements.', 'detailedDescription': 'The fixation of components in total hip arthroplasty has a significant effect on the long-term survival of the prostheses. Bone cement in total joint replacement acts as an anchoring medium for the prosthesis and provides a barrier to the ingress of wear debris into bone surfaces. However, there are significant differences in cement behaviour among differing types of cement. A clinical study based on the Norwegian Arthroplasty Register demonstrated that there is an increased rate of revision due to aseptic loosening of femoral components implanted with low-viscosity cement compared with that of high-viscosity.\n\nStudies have shown that high early migration for certain designs of femoral prosthesis can be a predictor for clinical loosening. RSA is a technique enabling calculation of the three-dimensional translational and rotational movements of the implant relative to the bone, and therefore provides an ideal technique to detect early micromotion of implants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients in need for total hip arthroplasty\n\nExclusion Criteria:\n\n* patients with an existing condition such as malignancy, pregnancy, severe osteoporosis and disabling musculoskeletal problems (other than in the hips),\n* patients on corticosteroid treatment,\n* patients who had already participated in a clinical study with an investigational product in the last 6 months.'}, 'identificationModule': {'nctId': 'NCT00837850', 'briefTitle': 'SmartSet HV and Palacos R RSA Bone Cements in Primary Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'A Randomised Prospective Trial of SmartSet HV and Palacos R Bone Cements in Primary Total Hip Arthroplasty. A Radiostereometric Analysis of the Charnley Femoral Component.', 'orgStudyIdInfo': {'id': '094-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Device: Bone cement 1']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Device: Bone cement 2']}], 'interventions': [{'name': 'Bone cement 1', 'type': 'DEVICE', 'otherNames': ['SmartSet HV'], 'description': 'Bone cement SmartSet® HV', 'armGroupLabels': ['1']}, {'name': 'Bone cement 2', 'type': 'DEVICE', 'otherNames': ['Palacos R'], 'description': 'Bone cement Palacos R', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Otto S. Husby, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St.Olavs hospital HF'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'DePuy International', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}