Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-01-03 @ 11:56 AM
Study NCT ID:
NCT00764894
Status:
TERMINATED
Last Update Posted:
2011-02-09
First Post:
2008-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Foundation Knee Study - Retrospective
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'whyStopped': 'Enrollment and data collection insufficient to continue study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-08', 'studyFirstSubmitDate': '2008-09-30', 'studyFirstSubmitQcDate': '2008-10-01', 'lastUpdatePostDateStruct': {'date': '2011-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The use and efficacy of the Encore Foundation Knee System', 'timeFrame': '2 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis', 'Post-traumatic Arthritis', 'Inflammatory Tissue Disorders', 'Arthritis Secondary to Other Diseases', 'Avascular Necrosis of the Femoral Condyles']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.djosurgical.com', 'label': 'Sponsor Company home page'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the use and efficacy of the Encore Foundation Knee System in a group of 200 patients for whom data has already been collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals who meet the indications for use of the Foundation Knee device AND who meet the inclusion/exclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have knee joint disease related to one or more of the following\n\n * osteoarthritis\n * post-traumatic arthritis\n * inflammatory tissue disorders\n * arthritis secondary to other diseases\n * Avascular necrosis of the femoral condyles;\n* Skeletal maturity\n* Less than 70 on the Knee Society Score (rating score)\n* Sufficient bone stock, as judged by radiographs, to support primary knee implant\n* Sufficient collateral ligaments to support the device, as judged by physician during stability testing (varus/valgus and flexion/extension) and less than 45 degree varus/valgus deformity and/or 90 degree flexion contracture\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* No infection present\n* No known materials sensitivity\n\nExclusion Criteria:\n\n* Skeletal immaturity\n* Greater than or equal to 70 on preoperative Knee Society Score (Rating Score)\n* Post-patellectomy\n* Insufficient bone quality which may affect implant stability\n* Insufficient collateral ligaments, as judged by the physician. Greater than 45 degree varus/valgus deformity and/or 90 degree flexion contracture.\n* Neurological conditions that might hinder patient's ability to follow study procedures (i.e., any that restrict physical activities such as Parkinson's Disease, Multiple Sclerosis, previous stroke which affects lower extremity)\n* Mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere with the patient's cognitive abilities, senile dementia, and Alzheimer's Disease)\n* Prisoners\n* Conditions that place excessive demand on the implant (i.e. Charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity)\n* Patient is pregnant\n* Infection present\n* Materials sensitivity"}, 'identificationModule': {'nctId': 'NCT00764894', 'briefTitle': 'Foundation Knee Study - Retrospective', 'organization': {'class': 'INDUSTRY', 'fullName': 'Encore Medical, L.P.'}, 'officialTitle': 'Post-Market Study of the Foundation Knee System', 'orgStudyIdInfo': {'id': 'PS - 701'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Foundation Knee', 'description': 'Retrospective data collection on 510(k) approved device', 'interventionNames': ['Device: Foundation Knee']}], 'interventions': [{'name': 'Foundation Knee', 'type': 'DEVICE', 'description': 'Subjects with degenerative joint disease (DJD), osteoarthritis or rheumatoid arthritis who received a primary Foundation Knee replacement and is willing to participate in the study.', 'armGroupLabels': ['Foundation Knee']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32960', 'city': 'Vero Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Hussamy Orthopedics', 'geoPoint': {'lat': 27.63864, 'lon': -80.39727}}], 'overallOfficials': [{'name': 'Omar Hussamy, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hussamy Orthopedics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Encore Medical, L.P.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Jane M. Jacob Ph.D.', 'oldOrganization': 'DJO Surgical'}}}}