Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-03-08 @ 3:39 AM
Study NCT ID:
NCT00848133
Status:
COMPLETED
Last Update Posted:
2009-02-20
First Post:
2009-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Subvastus and Midvastus Approaches in Minimally-Invasive Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}], '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-19', 'studyFirstSubmitDate': '2009-02-19', 'studyFirstSubmitQcDate': '2009-02-19', 'lastUpdatePostDateStruct': {'date': '2009-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Society Score', 'timeFrame': 'Final follow-up (minimum 24 months)'}], 'secondaryOutcomes': [{'measure': 'Radiographic alignment and fixation', 'timeFrame': 'Final follow-up (minimum 24 months)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Total Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare the early clinical outcomes of minimally invasive bilateral subvastus and midvastus approaches for total knee arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with advanced bilateral osteoarthritis of the knee for treatment with total knee arthroplasty\n* patients who wish to undergo bilateral total knee arthroplasty as part of a single surgical procedure\n\nExclusion Criteria:\n\n* patients who were previously treated with knee arthroplasty'}, 'identificationModule': {'nctId': 'NCT00848133', 'briefTitle': 'A Comparison of Subvastus and Midvastus Approaches in Minimally-Invasive Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Sinai Hospital of Baltimore'}, 'officialTitle': 'A Comparison of Subvastus and Midvastus Approaches in Minimally-Invasive Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'Bonutti_SV_MV_001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'mini-midvastus', 'interventionNames': ['Procedure: mini-midvastus surgical approach for total knee arthroplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'mini-subvastus', 'interventionNames': ['Procedure: mini-subvastus surgical approach for total knee arthroplasty']}], 'interventions': [{'name': 'mini-midvastus surgical approach for total knee arthroplasty', 'type': 'PROCEDURE', 'armGroupLabels': ['mini-midvastus']}, {'name': 'mini-subvastus surgical approach for total knee arthroplasty', 'type': 'PROCEDURE', 'armGroupLabels': ['mini-subvastus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62401', 'city': 'Effingham', 'state': 'Illinois', 'country': 'United States', 'facility': 'Bonutti Clinic', 'geoPoint': {'lat': 39.12004, 'lon': -88.54338}}], 'overallOfficials': [{'name': 'Michael A Mont, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sinai Hospital of Baltimore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinai Hospital of Baltimore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bonutti Clinic', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Peter Bonutti, MD', 'oldOrganization': 'Bonutti Clinic'}}}}