Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT01359527
Status:
COMPLETED
Last Update Posted:
2019-04-26
First Post:
2011-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dual Energy X-ray Absorptiometry (DXA) Comparison Hip Resurfacing Versus Total Hip Arthroplasty (THA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-25', 'studyFirstSubmitDate': '2011-05-22', 'studyFirstSubmitQcDate': '2011-05-23', 'lastUpdatePostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone Mineral Density', 'timeFrame': 'Baseline, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative', 'description': 'To evaluate the bone loss in the proximal femur resulting from hip resurfacing surgery and to compare this to the bone loss in the proximal femur resulting from total hip arthroplasty.'}], 'secondaryOutcomes': [{'measure': 'Harris Hip Score', 'timeFrame': 'Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative', 'description': 'Hip functional outcomes will be assessed using the Harris Hip Score'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Total Hip Replacement', 'Hip Resurfacing', 'Femoral Remodeling', 'Bone Loss', 'Bone Mineral Density', 'BMD', 'DXA', 'DEXA', 'THA'], 'conditions': ['Osteoarthritis, Hip']}, 'descriptionModule': {'briefSummary': 'This study compares the change (loss) of bone mineral density (BMD) that occurs in the proximal femur after hip resurfacing and total hip replacement.', 'detailedDescription': 'This study compares the change (loss) of bone mineral density (BMD) that occurs in the proximal femur after hip resurfacing and total hip replacement. The goal is to evaluate the bone loss in the proximal femur resulting from hip resurfacing surgery and to compare this to the bone loss in the proximal femur resulting from total hip arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing hip replacement or resurfacing for osteoarthritis', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age of at least 20 years\n* Osteoarthritis\n* Elective Total Hip Arthroplasty / Resurfacing\n* Signed Informed Consent\n\nExclusion Criteria:\n\n* Osteoporosis\n* Revisions\n* Femoral dysplasia\n* Trochanteric osteotomy\n* Inflammatory arthritis\n* Breast-feeding, pregnancy, or women of child-bearing potential without documentation of a negative pregnancy test and not utilizing contraception\n* Patients with a history of having taken or currently taking PTH, fluoride therapy or strontium ranelate or patients taking other chronic medications that in the Investigator's opinion are known to affect bone mineral density in a substantial way\n* Patients with severe medical condition(s) that in the view of the Investigator prohibits participation in the study\n* Use of any other investigational agent in the last 30 days"}, 'identificationModule': {'nctId': 'NCT01359527', 'briefTitle': 'Dual Energy X-ray Absorptiometry (DXA) Comparison Hip Resurfacing Versus Total Hip Arthroplasty (THA)', 'organization': {'class': 'OTHER', 'fullName': 'Spokane Joint Replacement Center'}, 'officialTitle': 'A Dual Energy X-Ray Absorptiometry Comparison Of Periprosthetic Bone Loss Between Patients Undergoing Hip Resurfacing Surgery And Total Hip Arthroplasty', 'orgStudyIdInfo': {'id': 'SJRC-RSRF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hip Resurfacing', 'interventionNames': ['Device: Hip Resurfacing']}, {'label': 'Total Hip Arthroplasty', 'interventionNames': ['Device: Total Hip Arthroplasty']}], 'interventions': [{'name': 'Hip Resurfacing', 'type': 'DEVICE', 'armGroupLabels': ['Hip Resurfacing']}, {'name': 'Total Hip Arthroplasty', 'type': 'DEVICE', 'armGroupLabels': ['Total Hip Arthroplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99218', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Spokane Joint Replacement Center', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'David Scott, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spokane Joint Replacement Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spokane Joint Replacement Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'David F. Scott, MD', 'investigatorAffiliation': 'Spokane Joint Replacement Center'}}}}