Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-31 @ 2:04 AM
Study NCT ID:
NCT03639532
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2018-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ceramic-on-Ceramic Versus Ceramic-on-HXLPE THA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D005271', 'term': 'Femur Head Necrosis'}], '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': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-19', 'studyFirstSubmitDate': '2018-08-15', 'studyFirstSubmitQcDate': '2018-08-19', 'lastUpdatePostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2003-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Harris hip score', 'timeFrame': '15 years after the intervention', 'description': 'The Harris Hip Score(HHS) was developed by William H. Harris to assess the results of hip surgery or hip replacement. The standard evaluation applies to various hip disabilities and methods of treatment in adults. The original version of the score was first published in 1969. 100 is the best score, and 0 is the worst possible score. HHS has a subset of pain(44 points), function(47 points), absence of deformity(4 points), and range of motion(5 points)'}], 'secondaryOutcomes': [{'measure': 'WOMAC(Western Ontario and McMaster Universities) Scores', 'timeFrame': '15 years after the intervention', 'description': 'A tool to evaluate patient function associated with knee. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). The total score is summed from individual sections, and 0 is the best possible score.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Hip', 'Avascular Necrosis of the Femoral Head', 'Arthropathy of Hip', 'Hip Arthr']}, 'referencesModule': {'references': [{'pmid': '23680502', 'type': 'BACKGROUND', 'citation': 'Bansal A, Khatib ON, Zuckerman JD. Revision total joint arthroplasty: the epidemiology of 63,140 cases in New York State. J Arthroplasty. 2014 Jan;29(1):23-7. doi: 10.1016/j.arth.2013.04.006. Epub 2013 May 13.'}, {'pmid': '24636903', 'type': 'BACKGROUND', 'citation': 'Kim YH, Park JW, Park JS. The 27 to 29-year outcomes of the PCA total hip arthroplasty in patients younger than 50 years old. J Arthroplasty. 2014 Dec;29(12):2256-61. doi: 10.1016/j.arth.2014.02.011. Epub 2014 Feb 12.'}, {'pmid': '20668972', 'type': 'BACKGROUND', 'citation': 'Clohisy JC, Oryhon JM, Seyler TM, Wells CW, Liu SS, Callaghan JJ, Mont MA. Function and fixation of total hip arthroplasty in patients 25 years of age or younger. Clin Orthop Relat Res. 2010 Dec;468(12):3207-13. doi: 10.1007/s11999-010-1468-4.'}, {'pmid': '23564363', 'type': 'BACKGROUND', 'citation': 'Adelani MA, Keeney JA, Palisch A, Fowler SA, Clohisy JC. Has total hip arthroplasty in patients 30 years or younger improved? A systematic review. Clin Orthop Relat Res. 2013 Aug;471(8):2595-601. doi: 10.1007/s11999-013-2975-x. Epub 2013 Apr 6.'}, {'pmid': '23783205', 'type': 'BACKGROUND', 'citation': 'Kim YH, Park JW, Patel C, Kim DY. Polyethylene wear and osteolysis after cementless total hip arthroplasty with alumina-on-highly cross-linked polyethylene bearings in patients younger than thirty years of age. J Bone Joint Surg Am. 2013 Jun 19;95(12):1088-93. doi: 10.2106/JBJS.L.01211.'}, {'pmid': '18922373', 'type': 'BACKGROUND', 'citation': "Capello WN, D'Antonio JA, Feinberg JR, Manley MT, Naughton M. Ceramic-on-ceramic total hip arthroplasty: update. J Arthroplasty. 2008 Oct;23(7 Suppl):39-43. doi: 10.1016/j.arth.2008.06.003."}, {'pmid': '19882338', 'type': 'BACKGROUND', 'citation': 'Bascarevic Z, Vukasinovic Z, Slavkovic N, Dulic B, Trajkovic G, Bascarevic V, Timotijevic S. Alumina-on-alumina ceramic versus metal-on-highly cross-linked polyethylene bearings in total hip arthroplasty: a comparative study. Int Orthop. 2010 Dec;34(8):1129-35. doi: 10.1007/s00264-009-0899-6. Epub 2009 Nov 1.'}]}, 'descriptionModule': {'briefSummary': 'Methods to reduce the revision rate of total hip arthroplasties (THAs) because of wear-related issues are important to examine, particularly because younger patients have a disproportionately high risk of revision. The investigators hoped to follow up patients and see if long-term Harris hip scores and WOMAC scores better in younger patients with a ceramic-on-ceramic (COC) THA compared with those with a ceramic-on-highly-cross-linked polyethylene (COP) THA.', 'detailedDescription': 'High success rates obtained in the general population have stimulated for total hip arthroplasty (THA) in young and active patients. Although there have been substantial improvements in THA, bearing surface wear and osteolysis are major factors limiting the durability of THAs in young and active patients. During the last decade, alternative bearings have been developed, including highly cross-linked polyethylene (HXLPE) and ceramic-on-ceramic (COC) bearings, with the potential to reduce wear and osteolysis in younger, more active patients.\n\nDespite contemporary cementless THA with COC bearings giving excellent clinical and radiographic outcomes, there is concern about squeaking, fracture of the ceramic head or acetabular insert or fretting and corrosion (trunnionosis). Although HXLPE have been reported to reduce polyethylene wear, there is concerned about a potential decrease in toughness, tensile strength and resistance to the propagation of fatigue cracks in a long-term follow-up.\n\nSeveral noncomparative studies of COC and COP THA have reported promising results in terms of Harris hip scores, radiographic findings, and survival rates, yet we are aware of no long-term comparative clinical studies with a COC THA and a COP THA in the same younger patients. This study aimed to see if long-term Harris hip scores and Western Ontario and McMaster Universities Osteoarthritis (WOMAC) score better in younger patients with a COC THA compared with those with a COP THA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* bilateral end-stage hip arthrosis\n\nExclusion Criteria:\n\n* inflammatory arthritis, foot and ankle disorders, dementia, stroke history, high dislocation of hip, patients older than 55 years'}, 'identificationModule': {'nctId': 'NCT03639532', 'briefTitle': 'Ceramic-on-Ceramic Versus Ceramic-on-HXLPE THA', 'organization': {'class': 'OTHER', 'fullName': 'Ewha Womans University'}, 'officialTitle': 'Is Ceramic-on-Ceramic THA Superior to Ceramic-on-Highly Cross-Linked Polyethylene THA in Patients Less Than 55 Years Old?', 'orgStudyIdInfo': {'id': 'HXLTHA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COC', 'description': 'for the arthritic hip of the patient, total hip arthroplasty(THA) with ceramic on ceramic(COC) bearing couple is implanted. The group with intervention COC THA.', 'interventionNames': ['Procedure: COC THA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'COP', 'description': 'for the arthritic hip of the patient, total hip arthroplasty(THA) with ceramic on highly cross-linked polyethylene bearing couple is implanted. The group with intervention COP THA.', 'interventionNames': ['Procedure: COP THA']}], 'interventions': [{'name': 'COC THA', 'type': 'PROCEDURE', 'description': 'standard total hip arthroplasty is done, with ceramic on ceramic for the bearing.', 'armGroupLabels': ['COC']}, {'name': 'COP THA', 'type': 'PROCEDURE', 'description': 'standard total hip arthroplasty is done, with ceramic on highly cross linked polyethylene for the bearing.', 'armGroupLabels': ['COP']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ewha Womans University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Young Hoo Kim', 'investigatorAffiliation': 'Ewha Womans University'}}}}