Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-28 @ 10:42 PM
Study NCT ID:
NCT01031732
Status:
UNKNOWN
Last Update Posted:
2010-05-31
First Post:
2009-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Four Surgical Techniques in Primary Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-05-27', 'studyFirstSubmitDate': '2009-12-13', 'studyFirstSubmitQcDate': '2009-12-14', 'lastUpdatePostDateStruct': {'date': '2010-05-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain and Harris hip score', 'timeFrame': '5 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months'}], 'secondaryOutcomes': [{'measure': 'Functional outcomes assessment', 'timeFrame': '6 weeks, 3 months, 6 months, 12 months, 24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Minimally invasive', 'Total hip arthroplasty', 'Functional outcome', 'To compare the surgical results of 4 MIS THA techniques', 'To investigate the functional outcomes of 4 MIS THA techniques', 'To study the biochemical parameters after the MIS surgeries.'], 'conditions': ['Arthroplasty, Replacement, Hip']}, 'referencesModule': {'references': [{'pmid': '19241897', 'type': 'BACKGROUND', 'citation': 'Chou SW, Ueng SW, Lee MS. Muscular recovery of hip flexors and extensors after two-incision total hip arthroplasty. Chang Gung Med J. 2008 Nov-Dec;31(6):576-82.'}, {'pmid': '18676112', 'type': 'BACKGROUND', 'citation': 'Chen DW, Hu CC, Chang YH, Yang WE, Lee MS. Comparison of clinical outcome in primary total hip arthroplasty by conventional anterolateral transgluteal or 2-incision approach. J Arthroplasty. 2009 Jun;24(4):528-32. doi: 10.1016/j.arth.2008.03.016. Epub 2008 Aug 3.'}, {'pmid': '18534477', 'type': 'BACKGROUND', 'citation': 'Hu CC, Yang WE, Chang YH, Chen DW, Ueng SW, Lee MS. Fluoroscopy cannot recognize intraoperative fracture in patients receiving 2-incision total hip arthroplasty. J Arthroplasty. 2008 Oct;23(7):1031-6. doi: 10.1016/j.arth.2007.09.026. Epub 2008 Mar 4.'}, {'pmid': '18350734', 'type': 'BACKGROUND', 'citation': 'Lu ML, Chou SW, Yang WE, Senan V, Hsieh PH, Shih HN, Lee MS. Hospital course and early clinical outcomes of two-incision total hip arthroplasty. Chang Gung Med J. 2007 Nov-Dec;30(6):513-20.'}, {'pmid': '19219827', 'type': 'BACKGROUND', 'citation': 'Lee MS, Kuo CH, Senan V, Chen WJ, Chen LH, Ueng SW. Two-incision total hip replacement: Intra-operative fluoroscopy versus imageless navigation for cup placement. Hip Int. 2006;16 Suppl 4:35-41. doi: 10.1177/112070000601604S08.'}], 'seeAlsoLinks': [{'url': 'http://www.cgmh.org.tw', 'label': 'Chang Gung Memorial Hospital'}, {'url': 'http://www.AAOS.org', 'label': 'American Academy of Orthopaedic Surgeons'}, {'url': 'http://www.cgu.edu.tw', 'label': 'Chang Gung University'}]}, 'descriptionModule': {'briefSummary': 'Current "Minimally Invasive THR" includes: (1) Minimally Invasive Two-Incision THR (MIS-2), (2) Minimally Invasive Modified Watson-Jones THR (MIS-WJ). In contrast, "mini-incision" utilizes smaller incision (\\< 10 cm in definition) to perform the THR which can further be divided into mini-anterolateral (Mini-AL) and mini-posterolateral (Mini-PL).The purpose of this study is to investigate how MIS THR can affect the results of THR by a prospective randomized clinical trial. It is hoped that some new standards could be established for the total hip replacement surgery.', 'detailedDescription': 'The prospective randomized study will be performed in patients after obtaining patient\'s consent. "Envelop drawing based on random table" will decide the choice of approach. (1) Group 1: MIS-2, 30 cases (2) Group 2: MIS-WJ, 30 cases (3) Group 3: Mini-AL, 30 cases (4) Group 4: Mini-PL, 30 cases. Only the unilateral coxarthrosis will be recruited for the study. Analytical methods include (1) gait analysis (2) cybex study (3) balance test and obstacle crossing test (4) bone densitometry (5) PETS oxygen consumption and glucose utilization tests (6) inflammatory markers (7) clinical assessment (8) X-ray studies. Patients will be scheduled for specified examinations preoperatively, postoperatively and within 5 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months, and 36 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral hip disease that is indicated for primary total hip arthroplasty.\n\nExclusion Criteria:\n\n* A previous THA on the contralateral hip.\n* Any condition contraindicated for primary total hip arthroplasty.\n* Refuse to be randomized in the study arms.'}, 'identificationModule': {'nctId': 'NCT01031732', 'briefTitle': 'Evaluation of Four Surgical Techniques in Primary Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'A Prospective Randomized Controlled 4-arm Study for the Evaluation of 4 Surgical Techniques in Primary Total Hip Arthroplasty', 'orgStudyIdInfo': {'id': '97-2177c'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Two-incision', 'description': 'MIS-2 THA', 'interventionNames': ['Procedure: MIS-2 THA']}, {'type': 'EXPERIMENTAL', 'label': 'Watson-Jones', 'description': 'MIS-WJ', 'interventionNames': ['Procedure: MIS-WJ']}, {'type': 'EXPERIMENTAL', 'label': 'MIS-AL', 'interventionNames': ['Procedure: MIS-AL THA']}, {'type': 'EXPERIMENTAL', 'label': 'MIS-PL', 'interventionNames': ['Procedure: MIS-PL THA']}], 'interventions': [{'name': 'MIS-2 THA', 'type': 'PROCEDURE', 'description': 'MIS two-incision THA', 'armGroupLabels': ['Two-incision']}, {'name': 'MIS-WJ', 'type': 'PROCEDURE', 'description': 'MIS-Watson Jones THA', 'armGroupLabels': ['Watson-Jones']}, {'name': 'MIS-AL THA', 'type': 'PROCEDURE', 'description': 'Transgluteal approach', 'armGroupLabels': ['MIS-AL']}, {'name': 'MIS-PL THA', 'type': 'PROCEDURE', 'description': 'Posterolateral approach', 'armGroupLabels': ['MIS-PL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Kweishan', 'state': 'Taoyuan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Mel S Lee, MD, PhD', 'role': 'CONTACT', 'email': 'mellee@adm.cgmh.org.tw', 'phone': '886-968372599'}, {'name': 'Mel S Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chang Gung Memorial Hospital'}], 'centralContacts': [{'name': 'Mel S Lee, MD, PhD', 'role': 'CONTACT', 'email': 'mellee@adm.cgmh.org.tw', 'phone': '886-968372599'}, {'name': 'Chihling Chou, RN', 'role': 'CONTACT', 'email': 'chihling0930@yahoo.com', 'phone': '886-968419384'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Janet George/Director, Corporate External Research', 'oldOrganization': 'Zimmer, Inc.'}}}}