Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-27 @ 7:19 PM
Study NCT ID:
NCT00764504
Status:
COMPLETED
Last Update Posted:
2011-04-19
First Post:
2008-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reverse Shoulder Prosthesis Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jane.jacob@djosurgical.com', 'phone': '512-832-9500', 'title': 'Manager of Clinical Affairs', 'phoneExt': '6323', 'organization': 'DJO Surgical'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Primary', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.', 'otherNumAtRisk': 156, 'otherNumAffected': 116, 'seriousNumAtRisk': 156, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Revision', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.', 'otherNumAtRisk': 162, 'otherNumAffected': 113, 'seriousNumAtRisk': 162, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Continued Access', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.', 'otherNumAtRisk': 249, 'otherNumAffected': 157, 'seriousNumAtRisk': 249, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anemia / Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Broken Device / Component', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Broken Screw', 'notes': 'screws are used to secure parts of the device to bone and will occasionally break.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 249, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 249, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death - Natural Causes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 249, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Device Instability / Failure', 'notes': 'Device became unstable or failed which required a revision surgery.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 249, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 249, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 249, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 249, 'numEvents': 23, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 249, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 249, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 81, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 64, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 249, 'numEvents': 103, 'numAffected': 68}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological disorder and numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 249, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 249, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 249, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 249, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'American Shoulder and Elbow Surgeons Shoulder Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.'}, {'id': 'OG001', 'title': 'Revision', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.'}, {'id': 'OG002', 'title': 'Continued Access', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'spread': '18.5', 'groupId': 'OG000'}, {'value': '62', 'spread': '18.5', 'groupId': 'OG001'}, {'value': '77', 'spread': '18.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-year', 'description': 'The patient self-report section of the ASES is a condition specific scale which is intended to measure functional limitations and pain of the shoulder. On a scale of 0 to 100, the use of their shoulder is measured with 0 = no use and 100 = full use. The assessment is done in two sections. One Pain (measured by the Visual Analog Pain Scale) and the second is a list of 10 questions referred to as the Activities of Daily Living. The results are calculated with the following equation:\n\n\\[(10 - Visual analog scale pain score) x 5\\] + \\[(5/3) x Cumulative ADL score\\]', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.'}, {'type': 'PRIMARY', 'title': 'Average Range of Motion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.'}, {'id': 'OG001', 'title': 'Revision', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.'}, {'id': 'OG002', 'title': 'Continued Access', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.'}], 'classes': [{'title': 'Active forward elevation', 'categories': [{'measurements': [{'value': '119.6', 'spread': '39.3', 'groupId': 'OG000'}, {'value': '84.4', 'spread': '36.5', 'groupId': 'OG001'}, {'value': '120.4', 'spread': '34.7', 'groupId': 'OG002'}]}]}, {'title': 'Active external rotation', 'categories': [{'measurements': [{'value': '33.3', 'spread': '19.0', 'groupId': 'OG000'}, {'value': '23.3', 'spread': '18.7', 'groupId': 'OG001'}, {'value': '37.1', 'spread': '24.2', 'groupId': 'OG002'}]}]}, {'title': 'Active cross body adduction', 'categories': [{'measurements': [{'value': '25.8', 'spread': '18.6', 'groupId': 'OG000'}, {'value': '13.9', 'spread': '15.6', 'groupId': 'OG001'}, {'value': '27.4', 'spread': '20.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-year', 'description': "Physician's assessment of a subject's range of motion in degrees.", 'unitOfMeasure': 'Angle of Degrees of Shoulder Motion', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.'}, {'type': 'PRIMARY', 'title': 'Subject Satisfaction With Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.'}, {'id': 'OG001', 'title': 'Revision', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.'}, {'id': 'OG002', 'title': 'Continued Access', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.'}], 'classes': [{'title': 'Excellent', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'Satisfactory', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Unsatisfactory', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-year', 'description': 'Each subject had a chance to rate their satisfaction with surgery at each study interval.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.'}, {'type': 'PRIMARY', 'title': 'Have Surgery Again?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.'}, {'id': 'OG001', 'title': 'Revision', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.'}, {'id': 'OG002', 'title': 'Continued Access', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-year', 'description': "Subject satisfaction: subject's willingness to have surgery performed again if necessary.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.'}, {'type': 'PRIMARY', 'title': 'Neer\'s "Limited Goals"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.'}, {'id': 'OG001', 'title': 'Revision', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.'}, {'id': 'OG002', 'title': 'Continued Access', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.'}], 'classes': [{'title': 'Yes - criteria met', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}, {'title': 'No - criteria not met', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-year', 'description': "To meet Neer's limited goals, a subject must report: none, slight or moderate pain with unusual activity and exhibit \\>90 degrees active forward elevation and exhibit \\>20 degrees of active external rotation.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.'}, {'type': 'PRIMARY', 'title': 'Radiographic Failures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.'}, {'id': 'OG001', 'title': 'Revision', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.'}, {'id': 'OG002', 'title': 'Continued Access', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-operative, 3-month, 6-month, 1-year, 2-year', 'description': 'Radiographic failure is defined as a shift in the position of the component \\>3mm or 3 degrees, a fracture of the cement mantle, a fracture of the component, or a \\>2mm radiolucency completely around either prosthesis.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects who came in for a 2 year visit and completed the x-ray portion of the exam.'}, {'type': 'PRIMARY', 'title': 'Safety Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.'}, {'id': 'OG001', 'title': 'Revision', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.'}, {'id': 'OG002', 'title': 'Continued Access', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.'}], 'classes': [{'title': 'Revisions of device', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Number of device related adverse events', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Total number of operative site adverse events', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-year', 'description': 'Number of device related adverse events and device failures at the 2 year time frame.', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'Adverse events were collected for all subjects who received the RSP device whether or not they were removed from the study at a later date due to protocol violation or consent issues.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Primary', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.'}, {'id': 'FG001', 'title': 'Revision', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.'}, {'id': 'FG002', 'title': 'Continued Access', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '141'}, {'groupId': 'FG002', 'numSubjects': '234'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '131'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '103'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Revision of Device', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '72'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}, {'value': '516', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Primary', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.'}, {'id': 'BG001', 'title': 'Revision', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.'}, {'id': 'BG002', 'title': 'Continued Access', 'description': 'Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}, {'value': '377', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.9', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '67.4', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '71.2', 'spread': '9.2', 'groupId': 'BG002'}, {'value': '70.4', 'spread': '10.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}, {'value': '320', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '196', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}, {'value': '516', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Operative Shoulder', 'classes': [{'title': 'Right', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}, {'value': '316', 'groupId': 'BG003'}]}]}, {'title': 'Left', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '200', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 516}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-21', 'studyFirstSubmitDate': '2008-09-30', 'resultsFirstSubmitDate': '2010-11-19', 'studyFirstSubmitQcDate': '2008-09-30', 'lastUpdatePostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-21', 'studyFirstPostDateStruct': {'date': '2008-10-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'American Shoulder and Elbow Surgeons Shoulder Score', 'timeFrame': '2-year', 'description': 'The patient self-report section of the ASES is a condition specific scale which is intended to measure functional limitations and pain of the shoulder. On a scale of 0 to 100, the use of their shoulder is measured with 0 = no use and 100 = full use. The assessment is done in two sections. One Pain (measured by the Visual Analog Pain Scale) and the second is a list of 10 questions referred to as the Activities of Daily Living. The results are calculated with the following equation:\n\n\\[(10 - Visual analog scale pain score) x 5\\] + \\[(5/3) x Cumulative ADL score\\]'}, {'measure': 'Average Range of Motion', 'timeFrame': '2-year', 'description': "Physician's assessment of a subject's range of motion in degrees."}, {'measure': 'Subject Satisfaction With Surgery', 'timeFrame': '2-year', 'description': 'Each subject had a chance to rate their satisfaction with surgery at each study interval.'}, {'measure': 'Have Surgery Again?', 'timeFrame': '2-year', 'description': "Subject satisfaction: subject's willingness to have surgery performed again if necessary."}, {'measure': 'Neer\'s "Limited Goals"', 'timeFrame': '2-year', 'description': "To meet Neer's limited goals, a subject must report: none, slight or moderate pain with unusual activity and exhibit \\>90 degrees active forward elevation and exhibit \\>20 degrees of active external rotation."}, {'measure': 'Radiographic Failures', 'timeFrame': 'Post-operative, 3-month, 6-month, 1-year, 2-year', 'description': 'Radiographic failure is defined as a shift in the position of the component \\>3mm or 3 degrees, a fracture of the cement mantle, a fracture of the component, or a \\>2mm radiolucency completely around either prosthesis.'}, {'measure': 'Safety Assessment', 'timeFrame': '2-year', 'description': 'Number of device related adverse events and device failures at the 2 year time frame.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rotator Cuff Arthropathy', 'Failed Total Shoulder', 'Failed Hemi-arthroplasty']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.djosurgical.com', 'label': 'Sponsor company home page'}]}, 'descriptionModule': {'briefSummary': 'The objective of this clinical study is to evaluate the safety and efficacy of the Encore Reverse Shoulder Prosthesis (RSP). The clinical results of the RSP will be compared to clinical results published in literature for rotator cuff arthropathy and salvage procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Irreparable rotator cuff or failed hemi or total shoulder arthroplasty with irreparable rotator cuff\n* Evidence of upward displacement of the humeral head with respect to the glenoid\n* Loss of glenohumeral joint space\n* Functional deltoid muscle\n* Patient is likely to be available for evaluation for the duration of the study\n* Visual Analog Pain Scale 5 or greater\n\nExclusion Criteria:\n\n* Non functional deltoid muscle\n* Active sepsis\n* Excessive glenoid bone loss\n* Pregnancy\n* Neurological abnormalities, which could hinder patient's ability or willingness to follow study procedures. For example, any that may restrict physical activities such as Parkinson's, Multiple Sclerosis, or previous stroke, which affects upper 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* Known metal allergy (i.e., jewelry).\n* Visual Analog Pain Scale \\<5."}, 'identificationModule': {'nctId': 'NCT00764504', 'acronym': 'RSP', 'briefTitle': 'Reverse Shoulder Prosthesis Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Encore Medical, L.P.'}, 'officialTitle': 'Encore Reverse Shoulder Prosthesis', 'orgStudyIdInfo': {'id': 'Study 300'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Primary', 'description': 'Primary shoulder', 'interventionNames': ['Device: Reverse Shoulder Prosthesis']}, {'type': 'EXPERIMENTAL', 'label': 'Revision', 'description': 'Revision shoulder', 'interventionNames': ['Device: Reverse Shoulder Prosthesis']}, {'type': 'EXPERIMENTAL', 'label': 'Continued Access', 'description': 'Primary shoulder subjects enrolled at a later date in order to collect more data.', 'interventionNames': ['Device: Reverse Shoulder Prosthesis']}], 'interventions': [{'name': 'Reverse Shoulder Prosthesis', 'type': 'DEVICE', 'description': 'For subjects with rotator cuff arthropathy and no previous shoulder device implanted.', 'armGroupLabels': ['Continued Access', 'Primary']}, {'name': 'Reverse Shoulder Prosthesis', 'type': 'DEVICE', 'description': 'For subjects with rotator cuff arthropathy and a failed hemi or total shoulder implant.', 'armGroupLabels': ['Revision']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Arthritis Orthopedics and Sports Medicine', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Orthopaedic Specialty Institute', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '80054', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80525', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Orthopedic Center of the Rockies', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '80124', 'city': 'Lonetree', 'state': 'Colorado', 'country': 'United States', 'facility': 'Advanced Orthopedic and Sports Medicine Specialists, P.C.', 'geoPoint': {'lat': 37.16806, 'lon': -107.17282}}, {'zip': '81657', 'city': 'Vail', 'state': 'Colorado', 'country': 'United States', 'facility': 'Steadman Hawkins SPT Medical Foundation', 'geoPoint': {'lat': 39.64026, 'lon': -106.3742}}, {'zip': '33462', 'city': 'Atlantis', 'state': 'Florida', 'country': 'United States', 'facility': 'Atlantis Orthopaedics', 'geoPoint': {'lat': 26.5909, 'lon': -80.10088}}, {'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Orthopaedic Surgery & Sports Medicine', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '33410', 'city': 'Palm Beach Gardens', 'state': 'Florida', 'country': 'United States', 'facility': 'Palm Beach Orthopaedic Institute', 'geoPoint': {'lat': 26.82339, 'lon': -80.13865}}, {'zip': '33637', 'city': 'Temple Terrace', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Orthopedic Institute', 'geoPoint': {'lat': 28.0353, 'lon': -82.38926}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '41017', 'city': 'Crestview', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Cincinnati Sports Medicine & Orthopaedic Center', 'geoPoint': {'lat': 39.02534, 'lon': -84.41744}}, {'zip': '21093', 'city': 'Lutherville', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.42122, 'lon': -76.62608}}, {'zip': '21204', 'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'Orthopedic Specialists', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'zip': '55431', 'city': 'Bloomington', 'state': 'Minnesota', 'country': 'United States', 'facility': 'TRIA Orthopaedic Center', 'geoPoint': {'lat': 44.8408, 'lon': -93.29828}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel 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'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Orthopedic Specialty Associates, P.A.', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Unlimited Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '75701', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Orthopedic Institute', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}], 'overallOfficials': [{'name': 'Mark Frankle, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida Orthopedic Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Encore Medical, L.P.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Jane M. Jacob Ph.D.', 'oldOrganization': 'DJO Surgical'}}}}