Ignite Creation Date:
2025-12-17 @ 3:58 PM
Ignite Modification Date:
2025-12-23 @ 10:13 PM
Study NCT ID:
NCT00764335
Status:
COMPLETED
Last Update Posted:
2018-03-20
First Post:
2008-10-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Unilateral vs Bilateral Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-16', 'studyFirstSubmitDate': '2008-10-01', 'studyFirstSubmitQcDate': '2008-10-01', 'lastUpdatePostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Hip']}, 'referencesModule': {'references': [{'pmid': '20544648', 'type': 'RESULT', 'citation': 'Husby VS, Bjorgen S, Hoff J, Helgerud J, Benum P, Husby OS. Unilateral vs. bilateral total hip arthroplasty - the influence of medial femoral head offset and effects on strength and aerobic endurance capacity. Hip Int. 2010 Apr-Jun;20(2):204-14. doi: 10.1177/112070001002000211.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the present study was to determine whether unilaterally operated total hip arthroplasty (THA) patients were superior to bilaterally operated THA patients with respect to aerobic endurance capacity, muscle strength and gait patterns 3-5 years after surgery, and to what extent medial femoral head offset (FO) influenced hip abductor strength.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects selected from orthopaedic out-patient department', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergone hip surgery 3-5 years ago\n* Age \\< 70 years\n\nExclusion Criteria:\n\n* Heart or lung diseases\n* Malign diseases\n* No muscle/skeletal diseases that compromises testing'}, 'identificationModule': {'nctId': 'NCT00764335', 'briefTitle': 'Unilateral vs Bilateral Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Unilateral vs Bilateral Total Hip Arthroplasty - the Influence of Medial Femoral Head Offset and Effects on Strength and Aerobic Endurance Capacity', 'orgStudyIdInfo': {'id': '4.2005.1527b'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'unilateral normal', 'description': 'total hip arthroplasty one side, normal offset of medial femoral head', 'interventionNames': ['Procedure: total hip arthroplasty one side']}, {'label': 'bilateral normal', 'description': 'total hip arthroplasty both sides, normal offset of medial femoral head', 'interventionNames': ['Procedure: total hip arthroplasty both sides']}, {'label': 'bilateral abnormal offset', 'description': 'total hip arthroplasty both sides, abnormal offset of medial femoral head', 'interventionNames': ['Procedure: total hip arthroplasty both sides']}, {'label': 'controls', 'description': 'Healthy, age-matched control group'}], 'interventions': [{'name': 'total hip arthroplasty one side', 'type': 'PROCEDURE', 'description': 'unilateral total hip arthroplasty', 'armGroupLabels': ['unilateral normal']}, {'name': 'total hip arthroplasty both sides', 'type': 'PROCEDURE', 'description': 'bilateral total hip arthroplasty', 'armGroupLabels': ['bilateral abnormal offset', 'bilateral normal']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jan Hoff, PhD prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'OrtoMedic A/S, Oslo', 'class': 'UNKNOWN'}, {'name': 'Scandinavian Customized Prosthesis (SCP)', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}