Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT01936259
Status:
COMPLETED
Last Update Posted:
2020-01-13
First Post:
2013-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comprehensive Shoulder System Nano IDE
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaldirector@zimmerbiomet.com', 'phone': '800-613-6131', 'title': 'Director of Clinical Operations', 'organization': 'Zimmer Biomet, Inc.'}, 'certainAgreement': {'otherDetails': 'The Investigator must provide the Sponsor with at least 30 days to review publications for legal and regulatory compliance and will include in publications a statement that the study was supported by the Sponsor. Sponsor confidential information will not be submitted for publication without Sponsor consent. Sponsor may request delay of publication for 60 days to allow for patent application filing.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the earlier of the date of study closure or the date of subject withdrawal, an average of 3.50 years.", 'description': 'Subjects are counted only once in each category, even if they experienced more than one adverse event in the specified category.', 'eventGroups': [{'id': 'EG000', 'title': 'Comprehensive Mini Humeral Stem', 'description': 'This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).', 'otherNumAtRisk': 130, 'deathsNumAtRisk': 130, 'otherNumAffected': 118, 'seriousNumAtRisk': 130, 'deathsNumAffected': 2, 'seriousNumAffected': 55}, {'id': 'EG001', 'title': 'Comprehensive Nano Humeral Component', 'description': 'This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).', 'otherNumAtRisk': 131, 'deathsNumAtRisk': 131, 'otherNumAffected': 105, 'seriousNumAtRisk': 131, 'deathsNumAffected': 3, 'seriousNumAffected': 41}], 'otherEvents': [{'term': 'Cardiac Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nerve Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other General (Non-Shoulder Related) Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 193, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 130, 'numAffected': 72}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Delayed Wound Healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislocation / Subluxation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Humeral Fracture or Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Implant or Part Failure or Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inadequate Range of Motion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loosening or Migration of Implants or Parts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nerve Deficit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unusual Shoulder Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 35, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 23, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound Problems: Dehiscence, Necrosis, Drainage, Superficial Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Shoulder-Related Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 95, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 88, 'numAffected': 52}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cardiac Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death (Non-Shoulder Related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other General (Non-Shoulder Related) Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 62, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 49, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislocation / Subluxation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Implant or Part Failure or Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Shoulder-Related Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "American Shoulder and Elbow Surgeon's Score (ASES)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comprehensive Mini Humeral Stem', 'description': 'This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).'}, {'id': 'OG001', 'title': 'Comprehensive Nano Humeral Component', 'description': 'This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).'}], 'classes': [{'categories': [{'measurements': [{'value': '92.20', 'spread': '13.51', 'groupId': 'OG000'}, {'value': '92.47', 'spread': '14.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '22+ Months', 'description': "The American Shoulder and Elbow Surgeon's (ASES) Score is a tool used to measure shoulder function. The ASES score is on a scale of 0 to 100, with 0 being the worst possible score and 100 the best. The score consists of two components - pain and activities of daily living.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Shoulders', 'denomUnitsSelected': 'Shoulders', 'populationDescription': 'All subjects with ASES data available at the two year visit were assessed.'}, {'type': 'PRIMARY', 'title': 'Number of Shoulders With Absence of Revision/Removal/UADE/Fracture/Dislocation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comprehensive Mini Humeral Stem', 'description': 'This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).'}, {'id': 'OG001', 'title': 'Comprehensive Nano Humeral Component', 'description': 'This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).'}], 'classes': [{'categories': [{'title': 'Success Shoulders', 'measurements': [{'value': '114', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}, {'title': 'Failure Shoulders', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '2 years', 'description': 'This outcome measure calculates the proportion of subjects meeting a success criteria defined in the protocol as "No unanticipated device-related adverse event, and no fracture, perforation of the bone or joint dislocation, and no fracture, perforation or dissociation of the device, and no revision or removal of any component." All subject records were evaluated for each of the disqualifying factors, and all subjects that failed at least one of the endpoint measures were identified. The success rate is defined as the number of subjects at two years not meeting any of the disqualifying factors compared to the total number of cases present at two years plus all subjects considered failures without two year data.', 'unitOfMeasure': 'Shoulders', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Shoulders', 'denomUnitsSelected': 'Shoulders', 'populationDescription': 'The total number of cases for each group includes all subjects with two year data, plus all subjects considered failures without two year data.'}, {'type': 'PRIMARY', 'title': 'Number of Shoulders With Radiographic Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comprehensive Mini Humeral Stem', 'description': 'This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).'}, {'id': 'OG001', 'title': 'Comprehensive Nano Humeral Component', 'description': 'This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).'}], 'classes': [{'categories': [{'title': 'Success Shoulders', 'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}, {'title': 'Failure Shoulders', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '2 years', 'description': 'This outcome measure calculates the proportion of subjects meeting a success criteria defined in the protocol as "Subsidence of the humeral component \\<5 mm, and migration of the humeral component \\<5 mm, and no progressive lucency around the humeral component \\>2 mm in two or more contiguous zones, and migration of the glenoid component \\<5 mm, and no progressive lucency \\>2 mm around the entire glenoid component." All subject records were evaluated by an Independent Radiographic Reviewer (IRR) at each time point for radiographic success based on these criteria.', 'unitOfMeasure': 'Shoulders', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Shoulders', 'denomUnitsSelected': 'Shoulders', 'populationDescription': 'All subjects at each time point were evaluated for radiographic success based on these criteria.'}, {'type': 'SECONDARY', 'title': "American Shoulder and Elbow Surgeon's Score (ASES)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comprehensive Mini Humeral Stem', 'description': 'This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).'}, {'id': 'OG001', 'title': 'Comprehensive Nano Humeral Component', 'description': 'This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.8', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '25.1', 'spread': '10.7', 'groupId': 'OG001'}]}]}, {'title': '6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.1', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '61.5', 'spread': '17.4', 'groupId': 'OG001'}]}]}, {'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.2', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '80.5', 'spread': '15.3', 'groupId': 'OG001'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.2', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '92.8', 'spread': '12.2', 'groupId': 'OG001'}]}]}, {'title': '2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92.2', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '92.5', 'spread': '14.9', 'groupId': 'OG001'}]}]}, {'title': '3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.0', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '90.0', 'spread': '17.8', 'groupId': 'OG001'}]}]}, {'title': '4 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.1', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '94.3', 'spread': '11.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative, 6 Weeks, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years', 'description': "The American Shoulder and Elbow Surgeon's (ASES) Score is a tool used to measure shoulder function. The ASES score is on a scale of 0 to 100, with 0 being the worst possible score and 100 the best. The score consists of two components - pain and activities of daily living.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Shoulders', 'denomUnitsSelected': 'Shoulders', 'populationDescription': 'All subjects with an ASES score collected at each specified study time period were assessed.'}, {'type': 'SECONDARY', 'title': 'Single Assessment Numeric Evaluation (SANE) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comprehensive Mini Humeral Stem', 'description': 'This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).'}, {'id': 'OG001', 'title': 'Comprehensive Nano Humeral Component', 'description': 'This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).'}], 'classes': [{'title': '6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.7', 'spread': '24.2', 'groupId': 'OG000'}, {'value': '53.7', 'spread': '23.9', 'groupId': 'OG001'}]}]}, {'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.4', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '80.7', 'spread': '16.1', 'groupId': 'OG001'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.4', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '92.2', 'spread': '9.3', 'groupId': 'OG001'}]}]}, {'title': '2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92.3', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '92.3', 'spread': '14.5', 'groupId': 'OG001'}]}]}, {'title': '3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.7', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '91.5', 'spread': '15.5', 'groupId': 'OG001'}]}]}, {'title': '4 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.4', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '93.0', 'spread': '12.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Weeks, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years', 'description': "The Single Assessment Numeric Evaluation (SANE) Score is a tool used to assess the subject's perception of their affected joint. Participants are requested to rate their shoulder function on a scale of 0 to 100, with 0 as the worst option and 100 being normal shoulder function.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Shoulders', 'denomUnitsSelected': 'Shoulders', 'populationDescription': 'All subjects with a SANE score collected at each specified study time period were assessed.'}, {'type': 'SECONDARY', 'title': 'Constant Score Adjusted for Age and Gender', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comprehensive Mini Humeral Stem', 'description': 'This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).'}, {'id': 'OG001', 'title': 'Comprehensive Nano Humeral Component', 'description': 'This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.2', 'spread': '17.1', 'groupId': 'OG000'}, {'value': '46.3', 'spread': '17.1', 'groupId': 'OG001'}]}]}, {'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.6', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '83.1', 'spread': '19.1', 'groupId': 'OG001'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.9', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '99.8', 'spread': '14.9', 'groupId': 'OG001'}]}]}, {'title': '2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.2', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '101.5', 'spread': '16.7', 'groupId': 'OG001'}]}]}, {'title': '3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.2', 'spread': '14.4', 'groupId': 'OG000'}, {'value': '99.2', 'spread': '17.3', 'groupId': 'OG001'}]}]}, {'title': '4 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.0', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '103.5', 'spread': '15.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years', 'description': "The Constant-Murley Shoulder Score is a scoring method used by clinicians to assess function of the shoulder. The standard score is on a scale of 0 to 100, with 0 being no shoulder function and 100 being excellent function. The age- and gender-adjusted Constant score normalizes the raw Constant score based on the subject's age and gender. The worst score on the adjusted scale is still 0, but the greatest scores can exceed 100 based on the calculations used for normalization. The scale used in this study was described by Katolik et al.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Shoulders', 'denomUnitsSelected': 'Shoulders', 'populationDescription': 'All subjects with a Constant score collected at each specified study time period were assessed. The score was not collected at 6 weeks to protect the subscapularis repair.'}, {'type': 'SECONDARY', 'title': 'Number of Shoulders Passing Radiographic Assessment of Radiolucencies and Subsidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}, {'units': 'Shoulders', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comprehensive Mini Humeral Stem', 'description': 'This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).'}, {'id': 'OG001', 'title': 'Comprehensive Nano Humeral Component', 'description': 'This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).'}], 'classes': [{'categories': [{'title': 'Success Shoulders', 'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}, {'title': 'Failure Shoulders', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '2+ years', 'description': 'All radiographs collected at all follow-up time points were analyzed by the Independent Radiographic reviewer. Subjects were assessed for the presence of radiolucencies considered to be failures of the radiographic co-primary endpoint (No progressive lucency around the humeral component \\>2 mm in two or more contiguous zones OR no progressive lucency \\>2 mm around the entire glenoid component) and for the presence of component subsidence. Subjects with the absence of failing radiolucencies and subsidence were considered successes.', 'unitOfMeasure': 'Shoulders', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Shoulders', 'denomUnitsSelected': 'Shoulders', 'populationDescription': 'All subject radiographs at all time points that were submitted to the Independent Radiographic Reviewer were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Comprehensive Mini Humeral Stem', 'description': 'This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).'}, {'id': 'FG001', 'title': 'Comprehensive Nano Humeral Component', 'description': 'This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '133', 'numSubjects': '130'}, {'groupId': 'FG001', 'numUnits': '132', 'numSubjects': '131'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '121', 'numSubjects': '118'}, {'groupId': 'FG001', 'numUnits': '112', 'numSubjects': '111'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '12', 'numSubjects': '12'}, {'groupId': 'FG001', 'numUnits': '20', 'numSubjects': '20'}]}]}], 'typeUnitsAnalyzed': 'Shoulders', 'recruitmentDetails': 'Due to competitive enrollment, one extra shoulder was randomized and enrolled into the study in the Control group as the site was not aware the study had reached full enrollment.\n\n258 individual subjects were enrolled in the study. 7 subjects underwent study procedures bilaterally, resulting in 265 shoulders enrolled in the study.', 'preAssignmentDetails': 'Subjects were randomized 1:1 to either the Comprehensive Shoulder System with Nano Humeral Component (Investigational) or the Comprehensive Shoulder System with Mini Humeral Stem (Control). Treatment assignments occurred intraoperatively and subjects remained blinded until completion of two-year follow-up for all subjects.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '258', 'groupId': 'BG002'}]}, {'units': 'Shoulders', 'counts': [{'value': '133', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '265', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Comprehensive Mini Humeral Stem', 'description': 'This arm will consist of all subjects implanted with the Control Device (Comprehensive Mini Humeral Stem).'}, {'id': 'BG001', 'title': 'Comprehensive Nano Humeral Component', 'description': 'This arm will consist of all subjects implanted with the Investigational Device (Comprehensive Nano Humeral Component).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.1', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '63.1', 'spread': '9.0', 'groupId': 'BG001'}, {'value': '62.6', 'spread': '9.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Shoulders'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Shoulders', 'denomUnitsSelected': 'Shoulders'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Shoulders', 'denomUnitsSelected': 'Shoulders'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '265', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Shoulders', 'denomUnitsSelected': 'Shoulders'}, {'title': 'Procedure on Unilateral/Bilateral Patient', 'classes': [{'title': 'Bilateral', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Unilateral', 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'description': 'Seven subjects underwent a study procedure on each shoulder, and are classified as bilateral subjects. This measure defines how many study devices were implanted in bilateral subjects and unilateral subjects.', 'unitOfMeasure': 'Shoulders', 'denomUnitsSelected': 'Shoulders'}], 'typeUnitsAnalyzed': 'Shoulders', 'populationDescription': '258 individual subjects were enrolled in the study. 7 subjects underwent study procedures bilaterally, resulting in 265 shoulders enrolled in the study. Of the 7 bilateral subjects, 1 received two investigational devices, 3 received two control devices, and 3 received one of each device.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-08-01', 'size': 604136, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-04T10:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 258}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-07', 'studyFirstSubmitDate': '2013-08-23', 'resultsFirstSubmitDate': '2019-11-05', 'studyFirstSubmitQcDate': '2013-09-03', 'lastUpdatePostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-07', 'studyFirstPostDateStruct': {'date': '2013-09-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "American Shoulder and Elbow Surgeon's Score (ASES)", 'timeFrame': '22+ Months', 'description': "The American Shoulder and Elbow Surgeon's (ASES) Score is a tool used to measure shoulder function. The ASES score is on a scale of 0 to 100, with 0 being the worst possible score and 100 the best. The score consists of two components - pain and activities of daily living."}, {'measure': 'Number of Shoulders With Absence of Revision/Removal/UADE/Fracture/Dislocation', 'timeFrame': '2 years', 'description': 'This outcome measure calculates the proportion of subjects meeting a success criteria defined in the protocol as "No unanticipated device-related adverse event, and no fracture, perforation of the bone or joint dislocation, and no fracture, perforation or dissociation of the device, and no revision or removal of any component." All subject records were evaluated for each of the disqualifying factors, and all subjects that failed at least one of the endpoint measures were identified. The success rate is defined as the number of subjects at two years not meeting any of the disqualifying factors compared to the total number of cases present at two years plus all subjects considered failures without two year data.'}, {'measure': 'Number of Shoulders With Radiographic Success', 'timeFrame': '2 years', 'description': 'This outcome measure calculates the proportion of subjects meeting a success criteria defined in the protocol as "Subsidence of the humeral component \\<5 mm, and migration of the humeral component \\<5 mm, and no progressive lucency around the humeral component \\>2 mm in two or more contiguous zones, and migration of the glenoid component \\<5 mm, and no progressive lucency \\>2 mm around the entire glenoid component." All subject records were evaluated by an Independent Radiographic Reviewer (IRR) at each time point for radiographic success based on these criteria.'}], 'secondaryOutcomes': [{'measure': "American Shoulder and Elbow Surgeon's Score (ASES)", 'timeFrame': 'Pre-operative, 6 Weeks, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years', 'description': "The American Shoulder and Elbow Surgeon's (ASES) Score is a tool used to measure shoulder function. The ASES score is on a scale of 0 to 100, with 0 being the worst possible score and 100 the best. The score consists of two components - pain and activities of daily living."}, {'measure': 'Single Assessment Numeric Evaluation (SANE) Score', 'timeFrame': '6 Weeks, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years', 'description': "The Single Assessment Numeric Evaluation (SANE) Score is a tool used to assess the subject's perception of their affected joint. Participants are requested to rate their shoulder function on a scale of 0 to 100, with 0 as the worst option and 100 being normal shoulder function."}, {'measure': 'Constant Score Adjusted for Age and Gender', 'timeFrame': 'Pre-operative, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years', 'description': "The Constant-Murley Shoulder Score is a scoring method used by clinicians to assess function of the shoulder. The standard score is on a scale of 0 to 100, with 0 being no shoulder function and 100 being excellent function. The age- and gender-adjusted Constant score normalizes the raw Constant score based on the subject's age and gender. The worst score on the adjusted scale is still 0, but the greatest scores can exceed 100 based on the calculations used for normalization. The scale used in this study was described by Katolik et al."}, {'measure': 'Number of Shoulders Passing Radiographic Assessment of Radiolucencies and Subsidence', 'timeFrame': '2+ years', 'description': 'All radiographs collected at all follow-up time points were analyzed by the Independent Radiographic reviewer. Subjects were assessed for the presence of radiolucencies considered to be failures of the radiographic co-primary endpoint (No progressive lucency around the humeral component \\>2 mm in two or more contiguous zones OR no progressive lucency \\>2 mm around the entire glenoid component) and for the presence of component subsidence. Subjects with the absence of failing radiolucencies and subsidence were considered successes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Shoulder', 'Joint', 'Osteoarthritis'], 'conditions': ['Joint Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to determine the safety and efficacy of the Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty (TSA).', 'detailedDescription': 'The purpose of this clinical investigation is to establish the safety and efficacy of the Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty. Safety and efficacy of the device will be measured by collection and analysis of the following data at the two-year or greater time point (22 months post-operative or longer):\n\n1. American Shoulder and Elbow Surgeons (ASES) Score\n2. Single Assessment Numeric Evaluation (SANE)\n3. Constant Score\n4. Radiographic assessment of osteolysis, radiolucencies, migration, and subsidence\n5. Comparison of overall adverse event rates including rates of removal/revision and other serious adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients for whom the surgeon has confirmed intraoperatively, has no cyst \\> 1cm and not more than one cyst at the implantation site\n* Patients with non-inflammatory degenerative joint disease including osteoarthritis.\n* Patients where the device will be used in the correction of a functional deformity (deformities preventing congruent articulation of the glenohumeral joint)\n* Patients with pain and/or loss of function in the shoulder for whom other treatment modalities have been unsuccessful.\n* Patients requiring unilateral or staged bilateral shoulder arthroplasty\n* Patient must be anatomically and structurally suited to receive the implants (humeral neck must be of sufficient diameter to implant at least the smallest nano humeral component and the humeral neck is intact).\n* Patients who are 21-90 years of age at the time of surgery and have reached skeletal maturity.\n* Patients with an ASES score ≤ 40.\n\nExclusion Criteria:\n\n* Patients diagnosed with avascular necrosis or post-traumatic arthritis of the humeral head\n* Patients found at the time of intraoperative examination to have a single cyst \\>1 cm in size or multiple cysts at the implantation site\n* Patient presents with shoulder joint infection, sepsis, osteomyelitis or distant foci of infections which may spread to the implant site.\n* Patients with cuff tear arthropathy.\n* Patients who have undergone a Hemi-, Total, or Reverse Total Shoulder arthroplasty in the affected shoulder.\n* Patient presents with a malunion or non-union of the tuberosities of the proximal humerus.\n* Patients with osteoporosis, osteomalacia, rheumatoid arthritis, metabolic disorders of bone, muscle or connective tissue, gross deformity or any other condition of the proximal humerus (defined as severe destruction or deformity of the proximal humerus that precludes placement of the device) that in the Investigator's medical judgment could compromise implant fixation or bone healing.\n* Rapid bone destruction, marked bone loss or bone resorption apparent on roentgenogram.\n* Patients with neurologic or other disorders that would either affect the stability of the shoulder prosthesis, i.e., Charcot's joint, uncontrolled seizures, etc., or would affect their capability or willingness to return to the clinic for assessments and/or follow directions.\n* Bone cancer, either primary or secondary, that affects the shoulder.\n* Patients presenting with symptoms of chronic steroid use. (oral steroids for a chronic condition for 12 months prior to and including the date of surgery)\n* Patients with a life expectancy of less than three years.\n* Patients diagnosed with severe shoulder instability\n* Patients diagnosed with subscapularis incompetence\n* Patients diagnosed with any condition that may limit their ability to complete the consent form or would affect their capability or willingness to return to the clinic for assessments and/or follow directions (i.e. mental illness)\n* Patients with known metal allergy\n* Patients who refuse to sign the Institutional Review Board (IRB) approved consent form\n* Patients who are found intraoperatively to require a specific treatment and are unable to be randomized."}, 'identificationModule': {'nctId': 'NCT01936259', 'acronym': 'Nano', 'briefTitle': 'Comprehensive Shoulder System Nano IDE', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'A Study of the Comprehensive Shoulder System With Nano Humeral Component in Total Shoulder Arthroplasty', 'orgStudyIdInfo': {'id': 'ORTHO.CA.GE1.12'}, 'secondaryIdInfos': [{'id': 'G110207', 'type': 'OTHER', 'domain': 'FDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Comprehensive Mini Humeral Stem', 'description': 'The Comprehensive® Shoulder System with mini stem component, which will be the control device for this clinical investigation and was 510(k) cleared under K060692 on May 30, 2006.\n\nThe humeral stem component is manufactured from Ti6Al4V alloy. The taper has a machine finish and accepts the taper adaptor of the humeral head component. The proximal region of the bone-contacting outer surface features a porous coating of plasma-sprayed titanium alloy, while the distal portion is polished. Seventeen stem diameters are available - 4 mm to 20 mm, in 1-mm increments.', 'interventionNames': ['Device: Mini Stem']}, {'type': 'EXPERIMENTAL', 'label': 'Comprehensive Nano Humeral Component', 'description': 'The stemless humeral component is manufactured from Ti6Al4V alloy. It consists of a central tapered region and six outer wings. The taper has a machine finish and accepts the taper adaptor of the humeral head component. A small groove is included just below the taper to accept an inserter/impactor. The bone-contacting outer surface features a porous coating of plasma-sprayed titanium alloy for cementless fixation in the proximal humerus. Six sizes are available - 30 mm, 32 mm, 34 mm, 36 mm, 38 mm, and 40 mm.', 'interventionNames': ['Device: Nano']}], 'interventions': [{'name': 'Mini Stem', 'type': 'DEVICE', 'description': 'The humeral stem component is manufactured from Ti6Al4V alloy. The taper has a machine finish and accepts the taper adaptor of the humeral head component. The proximal region of the bone-contacting outer surface features a porous coating of plasma-sprayed titanium alloy, while the distal portion is polished. Seventeen stem diameters are available - 4 mm to 20 mm, in 1-mm increments.', 'armGroupLabels': ['Comprehensive Mini Humeral Stem']}, {'name': 'Nano', 'type': 'DEVICE', 'description': 'The stemless humeral component is manufactured from Ti6Al4V alloy. It consists of a central tapered region and six outer wings. The taper has a machine finish and accepts the taper adaptor of the humeral head component. A small groove is included just below the taper to accept an inserter/impactor. The bone-contacting outer surface features a porous coating of plasma-sprayed titanium alloy for cementless fixation in the proximal humerus. Six sizes are available - 30 mm, 32 mm, 34 mm, 36 mm, 38 mm, and 40 mm.', 'armGroupLabels': ['Comprehensive Nano Humeral Component']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85255', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Institute for Sports, Knees, and Shoulders', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Holy Cross Hospital', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '46825', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Ortho NorthEast', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '71105', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Orthopedic Clinic', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '21204', 'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'Towson Orthopaedic Associates', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '14214', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University of Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '43054', 'city': 'New Albany', 'state': 'Ohio', 'country': 'United States', 'facility': 'Joint Implant Surgeons', 'geoPoint': {'lat': 40.08117, 'lon': -82.80879}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Campbell Clinic Orthopaedics', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '23114', 'city': 'Midlothian', 'state': 'Virginia', 'country': 'United States', 'facility': 'Bon Secours St. Francis Medical Center', 'geoPoint': {'lat': 37.50598, 'lon': -77.64916}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}