Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-29 @ 3:37 AM
Study NCT ID:
NCT00764803
Status:
TERMINATED
Last Update Posted:
2010-03-11
First Post:
2008-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3DKnee™ System vs. the MJS Knee System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'whyStopped': 'Corporate decision to discontinue distribution of MJS Knee.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-09', 'studyFirstSubmitDate': '2008-09-30', 'studyFirstSubmitQcDate': '2008-09-30', 'lastUpdatePostDateStruct': {'date': '2010-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System', 'timeFrame': '2 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis', 'Traumatic Arthritis', 'Joint Disease Secondary to Osteoarthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.djosurgical.com', 'label': 'Sponsor company home page'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System in a group of 600 patients for whom data collection is already under way.', 'detailedDescription': 'The purpose of this study is to compare the survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System in a group of 600 patients for whom data collection is already under way. Approximately 300 patients have already received the MJS™ knee system and data, as described below, has been collected for these patients over a period of two years. A second group of 300 patients will receive the Encore 3DKnee™ system over the next two years, and equivalent data will be collected for these individuals. A portion of the data has been collected over the past year, and now we would like to obtain permission from the patients to analyze these data as well as collect an additional year of data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals who meet either the indications for use of the 3DKnee or the MJS knee system. Subjects must also meet the inclusion/exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* This must be a primary knee replacement on this knee.\n* Patient is over 18 years of age or older\n* Patients must have one of the following\n\n * rheumatoid or traumatic arthritis OR\n * joint disease secondary to osteoarthritis\n* Patient is likely to be available for evaluation for the duration of the study\n* Able and willing to sign the informed consent and follow study procedures\n* Patient is not pregnant\n\nExclusion Criteria:\n\n* Is younger than 18 years of age\n* If there has been a total knee replacement on this knee in the past (no revisions allowed in study)\n* Overt infection\n* Alcoholism or other addictions\n* Muscular, neurological or vascular deficiencies which compromise the affected extremity\n* Obesity\n* Marked bone loss\n* Materials sensitivity\n* Prisoner\n* Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements\n* Patient is pregnant"}, 'identificationModule': {'nctId': 'NCT00764803', 'briefTitle': '3DKnee™ System vs. the MJS Knee System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Encore Medical, L.P.'}, 'officialTitle': 'Post-Market Study: The Efficacy of the 3DKnee™ System vs. the MJS Knee System', 'orgStudyIdInfo': {'id': 'PS - 702'}}, 'armsInterventionsModule': {'armGroups': [{'label': '2', 'description': 'Subjects who meet the indications for use and are implanted with the Encore MJS™ Knee System.', 'interventionNames': ['Device: Encore MJS™ Knee System']}, {'label': '1', 'description': 'Subjects who meet the indications for and are implanted with the Encore 3DKnee™ system.', 'interventionNames': ['Device: Encore 3DKnee™ system']}], 'interventions': [{'name': 'Encore 3DKnee™ system', 'type': 'DEVICE', 'description': 'Subjects with rheumatoid arthritis, traumatic arthritis or osteoarthritis who were implanted with the Encore 3DKnee™ system and willing to participate in the study.', 'armGroupLabels': ['1']}, {'name': 'Encore MJS™ Knee System', 'type': 'DEVICE', 'description': 'Subjects with rheumatoid arthritis, traumatic arthritis or osteoarthritis who were implanted with the Encore MJS™ Knee system and willing to participate in the study.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93710', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Center for Excellence', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}], 'overallOfficials': [{'name': 'D. Kevin Lester, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Excellence'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Encore Medical, L.P.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Jane M. Jacob Ph.D.', 'oldOrganization': 'DJO Surgical'}}}}