Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-26 @ 4:19 PM
Study NCT ID:
NCT02645435
Status:
COMPLETED
Last Update Posted:
2016-01-01
First Post:
2015-12-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Consequence of the Learning Curve in Direct Anterior Approach for Total Hip Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-31', 'studyFirstSubmitDate': '2015-12-29', 'studyFirstSubmitQcDate': '2015-12-31', 'lastUpdatePostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical outcome of direct hip approach', 'timeFrame': '32 months', 'description': "Harry's hip score, a clinical score used in orthopedic surgery to describe outcome of hip function"}], 'secondaryOutcomes': [{'measure': 'radiological positioning of cup in the replaced hip', 'timeFrame': '32 months', 'description': 'using standard x-ray of the hip placement of implants is measured in angles between the iliac line and component line for the cup'}, {'measure': 'radiological positioning of the stem in replaced hip', 'timeFrame': '32 months', 'description': 'using standard x-ray of the hip placement of implants is measured in angles between the axis of implant and femoral axis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arthropathy of Hip', 'Surgery']}, 'descriptionModule': {'briefSummary': 'Background:\n\nDirect anterior approach to the hip (DAA) is being considered as one of the most promising minimally-invasive approaches in total hip arthroplasty (THA). Purpose of this study is to analyse influence of learning curve on clinical and radiographic outcome in direct anterior approach (DAA) for total hip replacement.\n\nMethods:\n\nThe first 30 patients operated with DAA (group B) were compared to 39 patients operated by Hardinge approach (group A). Peri-and postoperative complications, Harris Hip Score (HHS), implant positioning, experienced pain and patient satisfaction were evaluated at a mean follow-up of 32 months.', 'detailedDescription': 'Direct anterior approach to the hip (DAA) is being considered as one of the most promising minimally-invasive approaches in total hip arthroplasty (THA). Purpose of this study is to analyse influence of learning curve on clinical and radiographic outcome in direct anterior approach (DAA) for total hip replacement.\n\nMethods:\n\nThe first 30 patients operated with DAA (group B) were compared to 39 patients operated by Hardinge approach (group A). Peri-and postoperative complications, Harris Hip Score (HHS), implant positioning, experienced pain and patient satisfaction were evaluated at a mean follow-up of 32 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hip arthritis\n\nExclusion Criteria:\n\n* BMI\\>35'}, 'identificationModule': {'nctId': 'NCT02645435', 'briefTitle': 'Consequence of the Learning Curve in Direct Anterior Approach for Total Hip Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera Bolognini di Seriate Bergamo'}, 'officialTitle': 'Consequence of the Learning Curve in Direct Anterior Approach for Total Hip Replacement', 'orgStudyIdInfo': {'id': 'AObolognini1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hip direct anterior approach', 'description': 'Patients with hip arthritis', 'interventionNames': ['Procedure: hip replacement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lateral hip approach', 'description': 'Patients with hip arthritis', 'interventionNames': ['Procedure: hip replacement']}], 'interventions': [{'name': 'hip replacement', 'type': 'PROCEDURE', 'description': 'Total hip replacement', 'armGroupLabels': ['Hip direct anterior approach', 'Lateral hip approach']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera Bolognini di Seriate Bergamo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Riccardo Compagnoni', 'investigatorAffiliation': 'Azienda Ospedaliera Bolognini di Seriate Bergamo'}}}}