Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-29 @ 5:46 PM
Study NCT ID:
NCT00764959
Status:
TERMINATED
Last Update Posted:
2011-02-09
First Post:
2008-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Study of the Linear™ Hip
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D010020', 'term': 'Osteonecrosis'}], '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'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, '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 Linear™ Hip System', 'timeFrame': '2 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis', 'Rheumatoid Arthritis', 'Femoral Fracture', 'Correction of a Functional Deformity', 'Avascular Necrosis']}, '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 Linear™ Hip 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 Linear Hip device AND who meet the inclusion/exclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have hip joint disease related to one or more of the following\n\n * osteoarthritis\n * rheumatoid arthritis\n * femoral fracture\n * correction of a functional deformity\n * avascular necrosis of the natural femoral head\n* Skeletal maturity\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* Patient is over 18 years of age\n\nExclusion Criteria:\n\n* Skeletal immaturity\n* Infection or sepsis\n* Insufficient bone quality that may affect the stability of the implant\n* Muscular, neurologic or vascular deficiencies which compromise the affected extremity\n* Alcoholism or other addictions\n* Prisoners\n* High levels of physical activity\n* Patient is pregnant\n* Loss of ligamentous structures\n* Materials sensitivity\n* Patient is under 18 years of age'}, 'identificationModule': {'nctId': 'NCT00764959', 'briefTitle': 'Retrospective Study of the Linear™ Hip', 'organization': {'class': 'INDUSTRY', 'fullName': 'Encore Medical, L.P.'}, 'officialTitle': 'Post-Market Study of the Linear™ Hip System', 'orgStudyIdInfo': {'id': 'PS - 800'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Linear Hip', 'description': 'Encore Linear Hip System', 'interventionNames': ['Device: Encore Linear™ Hip System']}], 'interventions': [{'name': 'Encore Linear™ Hip System', 'type': 'DEVICE', 'description': 'Subjects with degenerative joint disease (DJD), osteoarthritis or rheumatoid arthritis, have received the hip system and are willing to participate in the study.', 'armGroupLabels': ['Linear Hip']}]}, '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'}}}}