Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT01319227
Status:
UNKNOWN
Last Update Posted:
2016-08-30
First Post:
2011-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Periprosthetic Bone Remodeling Around Uncemented Components in 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-29', 'studyFirstSubmitDate': '2011-03-18', 'studyFirstSubmitQcDate': '2011-03-18', 'lastUpdatePostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Clinical outcome measures with validated scores comparing patients receiving different stems and acetabular components', 'timeFrame': 'Self administred validated score outcome measures after 6 weeks, after 3, 6, 12, 24 months and after 6 and 10 years', 'description': 'Validated scores included are Harris Hip Score (HHS), Euroqol 5-dimension (Eq5d) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)'}], 'primaryOutcomes': [{'measure': 'Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA)', 'timeFrame': 'bone mineral density (BMD) measured postoperatively at 2 years.'}, {'measure': 'Bone remodelling, i e change in bone mineral density behind the acetabular component, as measured with dual energy x-ray absorptiometry (DEXA)', 'timeFrame': 'bone mineral density (BMD) measured postoperatively at 2 years'}], 'secondaryOutcomes': [{'measure': 'Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis (RSA)', 'timeFrame': 'at 2 years'}, {'measure': 'Migration of acetabular components in six degrees of freedom and maximum total point motion of the head center measured with radiostereometric analysis (RSA)', 'timeFrame': 'at 2 years'}, {'measure': 'Migration of acetabular components in six degrees of freedom and maximum total point motion of the head center measured with radiostereometric analysis (RSA)', 'timeFrame': 'at 6 and 10 years'}, {'measure': 'Bone remodelling, i e change in bone mineral density around the stem and cup, as measured with dual energy x-ray absorptiometry (DEXA)', 'timeFrame': 'at 6 and 10 years.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Periprosthetic bone remodeling', 'Stress shielding', 'Short femoral stem', 'Porous Titanium Construct', 'Polyethylene wear'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '41410176', 'type': 'DERIVED', 'citation': 'Axenhus M, Salemyr M, Mukka S, Magneli M, Skoldenberg O. Long-term evaluation of periprosthetic bone changes in ultra-short versus conventional stems in total hip arthroplasty: a 10-year follow-up of a randomised controlled trial. Hip Int. 2025 Dec 18:11207000251371283. doi: 10.1177/11207000251371283. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized clinical trial comparing two different uncemented femoral stems and two different uncemented sockets using Dual-energy x-ray absorptiometry, Radiostereometry and clinical evaluation.\n\nHypothesis:\n\n1. A short uncemented stem gives less periprosthetic bone resorption in the proximal femur than a conventional uncemented stem.\n2. An uncemented acetabular component with a backside of three-dimensional Titanium porous construct gives less periprosthetic bone resorption than a backside covered with a conventional porous coating with Titanium-beads and a hydroxy-apatite layer.', 'detailedDescription': 'Consecutive patients 40-70 years old who are being planned for Total Hip Arthroplasty (THA) will be eligible for inclusion in the study.\n\nPeriprosthetic bone remodeling, migration of the components and clinical scores will be recorded prospectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 40-70 years old\n2. Primary osteoarthritis of the hip\n3. Type A or B femur according to Dorr10\n4. Femoral anatomy allowing implantation of both femoral stems\n5. Willingness and ability to follow study-protocol -\n\nExclusion Criteria:\n\n1. Inflammatory arthritis\n2. Abnormal femoral anatomy after hip dysplasia, not suitable for implantation of components\n3. Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months prior to surgery\n4. Ongoing oestrogen treatment\n5. Type C femur according to Dorr\n6. Not suited for the study for other reason (surgeons preference)'}, 'identificationModule': {'nctId': 'NCT01319227', 'acronym': 'PeriBRUSBRAC', 'briefTitle': 'Periprosthetic Bone Remodeling Around Uncemented Components in Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Danderyd Hospital'}, 'officialTitle': 'Periprosthetic Bone Remodeling Around Two Different Types of Uncemented Femoral Stems and Two Uncemented Acetabular Components in Total Hip Arthroplasty', 'orgStudyIdInfo': {'id': 'PeriBRUSBRAC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hip Arthroplasty, ultra-short stem, conventional cup', 'description': 'Hip replacement with a hydroxy-apatite covered ultra-short uncemented femoral stem and a conventional uncemented acetabular cup with hydroxy-apatite covered porous coating and a moderately cross-linked polyethylene cup liner', 'interventionNames': ['Procedure: Hip replacement']}, {'type': 'EXPERIMENTAL', 'label': 'Hip Arthroplasty, conventional stem, trabecular-titanium cup', 'description': 'Hip replacement with an uncemented tapered femoral stem and an uncemented acetabular cup with trabecular-Titanium backside and E-vitamin-treated polyethylene cup liner', 'interventionNames': ['Procedure: Hip replacement']}], 'interventions': [{'name': 'Hip replacement', 'type': 'PROCEDURE', 'otherNames': ['Ultra-short hydroxyapatite-coated Proxima stem and hydroxyapatite covered porous coated Pinnacle cup from DePuy, Johnson&Johnson.', 'Tapered, proximally porous and hydroxyapatite-coated, Bimetric stem and a Regenerex cup with trabecular-Titanium-backside from Biomet.'], 'description': 'Hip arthroplasty with uncemented components', 'armGroupLabels': ['Hip Arthroplasty, conventional stem, trabecular-titanium cup', 'Hip Arthroplasty, ultra-short stem, conventional cup']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18288', 'city': 'Stockholm', 'state': 'Stockholm County', 'country': 'Sweden', 'facility': 'Orthopaedic Department, Danderyd Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danderyd Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Orthopaedic Surgeon', 'investigatorFullName': 'Olof Skoldenberg', 'investigatorAffiliation': 'Danderyd Hospital'}}}}