Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT00894218
Status:
TERMINATED
Last Update Posted:
2014-02-25
First Post:
2009-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
New Tool of Subjective and Objective Functional Evaluation and the Quality of Life After Arthroplastic Surgery of the Hip and the Knee Assisted or Not by Computer and Mini-invasive Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001178', 'term': 'Arthroplasty'}], 'ancestors': [{'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-24', 'studyFirstSubmitDate': '2009-05-04', 'studyFirstSubmitQcDate': '2009-05-05', 'lastUpdatePostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the efficiency in short and medium-term functional impact parlance of two surgical techniques: computer-assisted surgery and mini-invasive surgery compared to the conventional techniques', 'timeFrame': '2 years after surgery'}], 'secondaryOutcomes': [{'measure': 'Ambulatory analysis of the walking and coordination of lower limbs, direct and indirect costs', 'timeFrame': '2 years after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hip Arthritis', 'Knee Arthritis']}, 'descriptionModule': {'briefSummary': 'Hip or knee arthroplasties allow a relief of pain and a good functional habilitative at patients suffering from degenerative osteoarthritis of these articulations with medium and long-term good results. The main objective of this study is to compare the efficiency in short and medium-term functional impact parlance of two surgical techniques: computer-assisted surgery and mini-invasive surgery compared to the conventional techniques thanks to an innovative technology of ambulatory analysis of walking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Weight \\< 100 kg\n* score UCLA \\> 4\n* prosthesis of first intention\n\nExclusion Criteria:\n\n* Pregnant\n* score UCLA \\< 4\n* osteotomy near to prosthesis\n* prosthesis requiring an osseous transplant\n* prosthesis already set up\n* infections, contagious diseases (HIV, tuberculosis, hepatitis, venereal diseases) or metastasis\n* neuromuscular diseases able to perturb walking or staying\n* congenital or acquired disease, or previous surgery able to have consequences on results and prosthesis survey according to the surgeon'}, 'identificationModule': {'nctId': 'NCT00894218', 'briefTitle': 'New Tool of Subjective and Objective Functional Evaluation and the Quality of Life After Arthroplastic Surgery of the Hip and the Knee Assisted or Not by Computer and Mini-invasive Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'orgStudyIdInfo': {'id': '2007-26'}, 'secondaryIdInfos': [{'id': '2007-A0084845'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional arthroplasty', 'description': 'Total hip or knee conventional arthroplasty', 'interventionNames': ['Procedure: Arthroplasty']}, {'type': 'EXPERIMENTAL', 'label': 'Mini-invasive arthroplasty', 'description': 'Total hip or knee mini-invasive arthroplasty', 'interventionNames': ['Procedure: Arthroplasty']}, {'type': 'EXPERIMENTAL', 'label': 'Mini-invasive and computer-assisted arthroplasty', 'description': 'Mini-invasive and computer-assisted total hip or knee arthroplasty', 'interventionNames': ['Procedure: Arthroplasty']}], 'interventions': [{'name': 'Arthroplasty', 'type': 'PROCEDURE', 'description': 'Hip or knee arthroplasty', 'armGroupLabels': ['Conventional arthroplasty', 'Mini-invasive and computer-assisted arthroplasty', 'Mini-invasive arthroplasty']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Marseille', 'country': 'France', 'facility': 'Assistance Publique-Hopitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}