Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-01-24 @ 5:55 AM
Study NCT ID:
NCT00293605
Status:
COMPLETED
Last Update Posted:
2011-05-09
First Post:
2006-02-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Cemented Stem Design on Periprosthetic Bone Mass Following Primary Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019644', 'term': 'Arthroplasty, Replacement, Hip'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood and Urine only'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-06', 'studyFirstSubmitDate': '2006-02-16', 'studyFirstSubmitQcDate': '2006-02-16', 'lastUpdatePostDateStruct': {'date': '2011-05-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proximal femoral BMD change over 2 years measured by DXA', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Clinical Evaluation using patient centered questionnaire (Oxford Hip Score)', 'timeFrame': '2 years'}, {'measure': 'Surgeon centered clinical assessment (Harris Hip Score)', 'timeFrame': '2 years'}, {'measure': 'Plain radiographic assessment', 'timeFrame': '2 years'}, {'measure': 'Biochemical markers of bone formation and resorption measured from serum and urine samples using the Elecsys system.', 'timeFrame': '2 years'}, {'measure': 'Femoral prosthetic stem y-axis migration (subsidence), ans stem/shaft angulation change measured by EBRA.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['aseptic loosening', 'femoral stem design'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Total hip replacement is a common procedure for the treatment of osteoarthrosis of the hips, the aims of this study are to determine the effect of implant stem design on bone quality surrounding the implant using three stem designs that are routinely implanted at this hospital.', 'detailedDescription': '120 patients will undergo routine hip replacements using either the C-Stem, Exeter Stem or Charnley stem implants. Patients will be clinically evaluated pre-operatively and randomised to one of the three implants. Post-operatively, patients will be clinically reviewed for 2 years using bone mineral density scans, radiological review, blood and urine analysis for bone markers and validated questionnaires to assess clinical data (Oxford Hip and Harries Hip). Patients will be assessed for prothesis migration using the EBRA methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pre-assessment clinics at Sheffield Hospitals, patients booked for hip replacements.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients must be aged 60 yrs or more uncomplicated primary or secondary osteoarthritis of the hip undergoing unilateral cemented total hip arthroplasty using a metal on polyethylene bearing couple.\n\nExclusion Criteria:\n\n* metabolic bone disorders, systemic disorders such as rheumatoid arthritis and patients who have taken pharmacological doses of oral steroids, hormone replacement therapy, tamoxifen, calcium or vitamin D supplements within the last year. Patients with a prior history of bisphosphonates and women of child bearing age.'}, 'identificationModule': {'nctId': 'NCT00293605', 'briefTitle': 'Effect of Cemented Stem Design on Periprosthetic Bone Mass Following Primary Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Sheffield Teaching Hospitals NHS Foundation Trust'}, 'officialTitle': 'Effect of Cemented Stem Design on Periprosthetic Bone Mass Following Primary Total Hip Arthroplasty', 'orgStudyIdInfo': {'id': 'NS200361715'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'C-stem implant', 'interventionNames': ['Procedure: Total Hip Replacement']}, {'label': '2', 'description': 'Charnley Implant', 'interventionNames': ['Procedure: Total Hip Replacement']}, {'label': '3', 'description': 'Exeter Implant', 'interventionNames': ['Procedure: Total Hip Replacement']}], 'interventions': [{'name': 'Total Hip Replacement', 'type': 'PROCEDURE', 'description': 'Implantation of one of 3 stem designs', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S5 7AU', 'city': 'Sheffield', 'state': 'South Yorkshire', 'country': 'United Kingdom', 'facility': 'Orthopaedic Department, Northern General Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Andrew J Hamer, FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'STH NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheffield Teaching Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Mr Andrew Hamer', 'oldOrganization': 'Sheffield NHS Foundation Trust'}}}}