Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT00698867
Status:
COMPLETED
Last Update Posted:
2017-08-07
First Post:
2008-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Clinical Investigation of the Discovery™ Elbow System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D006810', 'term': 'Humeral Fractures'}], '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': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kelly.francher@zimmerbiomet.com', 'phone': '574-371-9783', 'title': 'Kelly Francher, Clinical Affairs Manager', 'organization': 'Zimmer Biomet'}, 'certainAgreement': {'otherDetails': 'A publication which uses data in addition to the authors will be reviewed by all who have contributed data, and all of the contributors will be recognized. All publications will be reviewed by BIOMET at least 30 days prior to publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the time of enrollment to the time of study completion (5 year visit). The numbers at risk refer to the number of elbows implanted.', 'eventGroups': [{'id': 'EG000', 'title': 'Discovery™ Elbow', 'description': 'Discovery™ Elbow minimally constrained', 'otherNumAtRisk': 118, 'otherNumAffected': 32, 'seriousNumAtRisk': 118, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Fracture Near Operative Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Patient Fell', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stitch Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Olecranon and Triceps Deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Motor Vehicle Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Elbow Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Perforation Anterior Medical Proximal Ulna', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ulnar Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Foreign Body Reaction/Excision Olecranon Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Elbow Squeaking', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'MCP Replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Coagulase Negative Staph Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Posterior Screw Backing Out', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Humeral radiolucency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Humeral Component Loosening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Posterior Nerve Palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Painful Lateral Elbow', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound Drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Olecranon Impingement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insidious Onset Edema Elbow', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ectopic Bone Formation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Elbow Contracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Left shoulder arthroplasty due to rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection requiring intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Humeral Fracture', 'notes': 'Postoperative humeral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sucutaneous Abscess', 'notes': 'Patient developed 2 subcutaneous abscesses both requiring operative intervention. One abscess was located on the right dorsal wrist and the second was located on the plantar aspect of the right foot.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-op Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'GI Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Loosening of total elbow', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-elbow Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Elbow Contracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Failed Ulnar Bushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Resection of Distal Ulna', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'American Shoulder and Elbow Society Score (ASES) Pain Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Elbows', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Discovery™ Elbow', 'description': 'Discovery™ Elbow minimally constrained'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '7.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': "This is a patient reported outcome measure that indicates the patient's pain as measured on the ASES form. The maximum pain score is 50 and the minimum score is 0. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Elbows', 'denomUnitsSelected': 'Elbows', 'populationDescription': 'Discovery Elbow'}, {'type': 'PRIMARY', 'title': 'Patient Derived American Shoulder and Elbow Society Score (ASES) Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Elbows', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Discovery™ Elbow', 'description': 'Discovery™ Elbow minimally constrained'}], 'classes': [{'categories': [{'measurements': [{'value': '29.7', 'spread': '7.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 Years', 'description': 'This is a measure of patient function as answered by the patient. The maximum score is 36 and the minimum is 0. The maximum score represents maximum function.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Elbows', 'denomUnitsSelected': 'Elbows', 'populationDescription': 'Discovery elbows'}, {'type': 'PRIMARY', 'title': 'Patient Derived American Shoulder and Elbow Society Score (ASES) Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Elbows', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Discovery™ Elbow', 'description': 'Discovery™ Elbow minimally constrained'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'spread': '2.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 Years', 'description': 'This is a measure of patient satisfaction as answered by the patient. The maximum score is 10 and the minimum is 0. The maximum score indicates maximum satisfaction.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Elbows', 'denomUnitsSelected': 'Elbows'}, {'type': 'PRIMARY', 'title': 'Surgeon Derived American Shoulder and Elbow Society Score (ASES) Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Elbows', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Discovery™ Elbow', 'description': 'Discovery™ Elbow minimally constrained'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '1.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 Years', 'description': 'This is a measure of the elbow signs as reported by the investigator. Signs include various assessments of joint tenderness, impingement, and pain in range of motion. The maximum score is 39 and the minimum is 0. The maximum score indicates the most abnormal signs.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Elbows', 'denomUnitsSelected': 'Elbows'}, {'type': 'PRIMARY', 'title': 'Surgeon Derived American Shoulder and Elbow Society Score (ASES) Stability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Elbows', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Discovery™ Elbow', 'description': 'Discovery™ Elbow minimally constrained'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 Years', 'description': 'Surgeon assessment of patient elbow stability. Maximum instability score is 9 and the minimum is 0. The maximum score indicates the least stability.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Elbows', 'denomUnitsSelected': 'Elbows'}, {'type': 'PRIMARY', 'title': 'Surgeon Derived American Shoulder and Elbow Society Score (ASES) Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Elbows', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Discovery™ Elbow', 'description': 'Discovery™ Elbow minimally constrained'}], 'classes': [{'categories': [{'measurements': [{'value': '19.8', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 Years', 'description': 'Measure of elbow strength as defined by the investigator. Maximum score is 20 and the minimum is 0. The maximum score indicates maximum strength.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Elbows', 'denomUnitsSelected': 'Elbows'}, {'type': 'SECONDARY', 'title': 'Incidence of Surviving Elbows', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}, {'units': 'Elbows', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Discovery™ Elbow', 'description': 'Discovery™ Elbow minimally constrained'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9778', 'groupId': 'OG000', 'lowerLimit': '0.9347', 'upperLimit': '1.0000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 Years', 'description': 'Proportion of elbows that did not require revision or removal', 'unitOfMeasure': 'Proportion of Elbows', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Elbows', 'denomUnitsSelected': 'Elbows', 'populationDescription': 'Subjects with complete 5 year data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Discovery™ Elbow', 'description': 'Discovery™ Elbow minimally constrained'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '118', 'numSubjects': '118'}]}, {'type': 'Subjects With 1 Year Data', 'achievements': [{'groupId': 'FG000', 'numUnits': '68', 'numSubjects': '68'}]}, {'type': 'Subjects With 2 Year Data', 'achievements': [{'groupId': 'FG000', 'numUnits': '55', 'numSubjects': '55'}]}, {'type': 'Subjects With 3 Year Data', 'achievements': [{'groupId': 'FG000', 'numUnits': '35', 'numSubjects': '35'}]}, {'type': 'Subjects With 4 Year Data', 'achievements': [{'groupId': 'FG000', 'numUnits': '34', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '27', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '91', 'numSubjects': '91'}]}]}], 'typeUnitsAnalyzed': 'Elbows'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Discovery™ Elbow', 'description': 'Discovery™ Elbow minimally constrained'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Less than 20', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '20-29', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': '30-39', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': '40-49', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': '50-59', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}, {'title': '60-69', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}, {'title': '70-79', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': '80-89', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': '90-99', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Elbows'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'elbows'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'elbows'}, {'title': 'Hand Dominance', 'classes': [{'title': 'Ambidextrous', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Left', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Right', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'elbows'}, {'title': 'Primary Diagnosis', 'classes': [{'title': 'Functional Deformity', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Humeral Fracture', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'Osteoarthritis', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Other Inflammatory Arthroses', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Rheumatoid Arthritis', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}, {'title': 'Traumatic Arthritis', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Ulnar Fracture', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Recurrent Dislocation/Stability', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Revision Surgery', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'elbows'}], 'populationDescription': 'Elbows with preoperative data'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-28', 'studyFirstSubmitDate': '2008-06-13', 'resultsFirstSubmitDate': '2016-09-20', 'studyFirstSubmitQcDate': '2008-06-13', 'lastUpdatePostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-28', 'studyFirstPostDateStruct': {'date': '2008-06-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'American Shoulder and Elbow Society Score (ASES) Pain Assessment', 'timeFrame': '5 years', 'description': "This is a patient reported outcome measure that indicates the patient's pain as measured on the ASES form. The maximum pain score is 50 and the minimum score is 0. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain."}, {'measure': 'Patient Derived American Shoulder and Elbow Society Score (ASES) Function', 'timeFrame': '5 Years', 'description': 'This is a measure of patient function as answered by the patient. The maximum score is 36 and the minimum is 0. The maximum score represents maximum function.'}, {'measure': 'Patient Derived American Shoulder and Elbow Society Score (ASES) Satisfaction', 'timeFrame': '5 Years', 'description': 'This is a measure of patient satisfaction as answered by the patient. The maximum score is 10 and the minimum is 0. The maximum score indicates maximum satisfaction.'}, {'measure': 'Surgeon Derived American Shoulder and Elbow Society Score (ASES) Signs', 'timeFrame': '5 Years', 'description': 'This is a measure of the elbow signs as reported by the investigator. Signs include various assessments of joint tenderness, impingement, and pain in range of motion. The maximum score is 39 and the minimum is 0. The maximum score indicates the most abnormal signs.'}, {'measure': 'Surgeon Derived American Shoulder and Elbow Society Score (ASES) Stability', 'timeFrame': '5 Years', 'description': 'Surgeon assessment of patient elbow stability. Maximum instability score is 9 and the minimum is 0. The maximum score indicates the least stability.'}, {'measure': 'Surgeon Derived American Shoulder and Elbow Society Score (ASES) Strength', 'timeFrame': '5 Years', 'description': 'Measure of elbow strength as defined by the investigator. Maximum score is 20 and the minimum is 0. The maximum score indicates maximum strength.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Surviving Elbows', 'timeFrame': 'Up to 5 Years', 'description': 'Proportion of elbows that did not require revision or removal'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Total Elbow Arthroplasty', 'Total Elbow Replacement', 'Osteoarthritis', 'Elbow arthritis'], 'conditions': ['Osteoarthritis', 'Rheumatoid Arthritis', 'Avascular Necrosis', 'Humeral Fractures']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to perform a five-year, multi-center prospective evaluation of the Discovery™ Elbow System for outcome and durability. Relief of pain and restoration of function will determine long-term clinical outcome while durability will be measured by the absence of revisions.', 'detailedDescription': 'Patient follow-up outcomes measured by the ASES score, radiographs and adverse events/revisions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in need of relief from painful or disabling Joint Disease in need of total elbow replacment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.\n* Inflammatory arthritis\n* Revision where other devices or treatments have failed\n* Correction of functional deformity\n* Treatment of acute fractures or non-union about the elbow\n\nPatient Selection factors to be considered include:\n\n* Need to obtain pain relief and improve function.\n* Ability and willingness to follow instructions including control of weight and activity levels.\n* Patients who are able and willing to return for follow-up evaluations.\n* Patients with a good nutritional state.\n* Patients with full skeletal maturity.\n* Patients of all races and gender.\n* Patients who are able to follow care instructions.\n\nExclusion Criteria:\n\n* Patients less than 18 years.\n* Patients with marked bone loss which would preclude proper fixation of the prosthesis.\n* Metabolic disorders, which may impair bone formation.\n* Patients who are pregnant.\n* Patients with an active or suspected infection in or around the elbow or distant foci of infections, which may spread to the implant site.\n* Patients with a highly communicable disease or diseases that may limit follow-up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis, neoplastic disease, etc.).\n* Patients unwilling or unable to comply with a rehabilitation program for elbow replacement or who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.\n* Patients who qualify for inclusion in the study, but refuse consent to participate in the study.'}, 'identificationModule': {'nctId': 'NCT00698867', 'briefTitle': 'A Clinical Investigation of the Discovery™ Elbow System', 'nctIdAliases': ['NCT00515515'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'A Prospective, Non-controlled, Clinical Investigation of the Discovery™ Elbow System', 'orgStudyIdInfo': {'id': 'ORTHO.CR.EX001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Discovery™ Elbow', 'description': 'Discovery™ Elbow minimally constrained'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33637', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Orthopedic Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Hand to Shoulder Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Hand Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Russell Schenck, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director, Clinical Research, Biomet Orthopedics, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biomet Orthopedics, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}