Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT00208351
Status:
TERMINATED
Last Update Posted:
2016-05-11
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomised Single Centre Study to Compare the Long-term Performance of 4 Designs of the DePuy Ultima LX Stem in Primary Total Hip Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D006618', 'term': 'Hip Dislocation, Congenital'}, {'id': 'D060048', 'term': 'Slipped Capital Femoral Epiphyses'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000082602', 'term': 'Developmental Dysplasia of the Hip'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010009', 'term': 'Osteochondrodysplasias'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D004839', 'term': 'Epiphyses, Slipped'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}}, 'statusModule': {'whyStopped': 'The final assessments were conducted late and in a reduced format due to resource limitations at the site.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '1997-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-09', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stem movement measured radiographically at 2 years', 'timeFrame': '2yrs post-surgery', 'description': 'Stem movement was measured radiographically by comparing baseline stem position with the stem position 2 years after surgery. If migration was observed to be 5 or more mm, it was considered clinically significant migration.'}], 'secondaryOutcomes': [{'measure': 'Comparisons of Visual Analog Pain (VAS), 36-Item Short Form Health Survey (SF-36), Satisfaction, Limb Length and stem movement measured radiographically at 5 years.', 'timeFrame': '5yrs post-surgery', 'description': 'The following outcome measures were used; VAS Pain score, SF36 Patient reported outcome, Satisfaction, Limb Length physical examination, and stem movement measured radiographically.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hip', 'Cemented'], 'conditions': ['Osteoarthritis', 'Post-traumatic Arthritis', 'Collagen Disorder', 'Avascular Necrosis', 'Traumatic Femoral Fractures', 'Nonunion of Femoral Fractures', 'Congenital Hip Dysplasia', 'Slipped Capital Femoral Epiphysis']}, 'referencesModule': {'references': [{'pmid': '24474088', 'type': 'RESULT', 'citation': 'Hutt J, Hazlerigg A, Aneel A, Epie G, Dabis H, Twyman R, Cobb A. The effect of a collar and surface finish on cemented femoral stems: a prospective randomised trial of four stem designs. Int Orthop. 2014 Jun;38(6):1131-7. doi: 10.1007/s00264-013-2256-z. Epub 2014 Jan 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the performance of 4 designs of the DePuy Ultima LX hip stem in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to one of the 4 designs of the DePuy Ultima LX hip stem and will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCurrent indications for primary total hip arthroplasty utilising a cemented femoral component. These include pain, deformity and loss of function which are not responsive to medical treatment\n\nExclusion Criteria:\n\ni) Revision Total Hip Arthroplasty ii) Rheumatoid arthritis iii) Age greater than 80 years at time of surgery iv) Age less than 60 years at time of surgery v) Previous hip joint sepsis vi) Obesity vii) Patient likely to remain housebound once rehabilitation is complete'}, 'identificationModule': {'nctId': 'NCT00208351', 'briefTitle': 'A Randomised Single Centre Study to Compare the Long-term Performance of 4 Designs of the DePuy Ultima LX Stem in Primary Total Hip Replacement', 'organization': {'class': 'INDUSTRY', 'fullName': 'DePuy International'}, 'officialTitle': 'Clinical and Radiographic Evaluation to Compare a Polished and Non-polished Collared Stem and a Polished and Non Polished Collarless Stem in Primary Total Hip Replacement', 'orgStudyIdInfo': {'id': 'CT01/95'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1) Ultima LX Collared Stem - Non-Polished/Blasted Finished', 'description': 'A collared non-polished blasted finished cementless femoral component for use in total hip replacement.', 'interventionNames': ['Device: Ultima LX Collared Stem - Non-Polished/Blasted Finished']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2) Ultima LX Collared Stem - Polished Finished', 'description': 'A collared polished finished cementless femoral component for use in total hip replacement.', 'interventionNames': ['Device: Ultima LX Collared Stem - Polished Finished']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3) Ultima LX Collarless Stem - Non-Polished/Blasted Finished', 'description': 'A collarless non-polished/blasted finished cementless femoral component for use in total hip replacement.', 'interventionNames': ['Device: Ultima LX Collarless Stem - Non-Polished/Blasted Finished']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4) Ultima LX Collarless Stem - Polished Finished', 'description': 'A collarless polished finished cementless femoral component for use in total hip replacement.', 'interventionNames': ['Device: Ultima LX Collarless Stem - Polished finished']}], 'interventions': [{'name': 'Ultima LX Collared Stem - Non-Polished/Blasted Finished', 'type': 'DEVICE', 'description': 'A collared non-polished/blasted finished cementless femoral component for use in total hip replacement.', 'armGroupLabels': ['1) Ultima LX Collared Stem - Non-Polished/Blasted Finished']}, {'name': 'Ultima LX Collared Stem - Polished Finished', 'type': 'DEVICE', 'description': 'A collared polished finished cementless femoral component for use in total hip replacement.', 'armGroupLabels': ['2) Ultima LX Collared Stem - Polished Finished']}, {'name': 'Ultima LX Collarless Stem - Non-Polished/Blasted Finished', 'type': 'DEVICE', 'description': 'A collarless non-polished/blasted finished cementless femoral component for use in total hip replacement.', 'armGroupLabels': ['3) Ultima LX Collarless Stem - Non-Polished/Blasted Finished']}, {'name': 'Ultima LX Collarless Stem - Polished finished', 'type': 'DEVICE', 'description': 'A collarless polished finished cementless femoral component for use in total hip replacement.', 'armGroupLabels': ['4) Ultima LX Collarless Stem - Polished Finished']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'KT18 7EG', 'city': 'Surrey', 'country': 'United Kingdom', 'facility': 'Epsom General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DePuy International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}