Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:44 PM
Study NCT ID:
NCT00436969
Status:
COMPLETED
Last Update Posted:
2017-03-09
First Post:
2007-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
ORTHOVISC Shoulder Osteoarthritis Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amichae2@its.jnj.com', 'phone': '508.828.3337', 'title': 'Aileen Michael', 'organization': 'DePuy Mitek'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months', 'description': 'All subjects that received study treatment are included in the safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine)and 2 mL of corticosteroid (Celestone).', 'otherNumAtRisk': 87, 'otherNumAffected': 6, 'seriousNumAtRisk': 87, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.", 'otherNumAtRisk': 183, 'otherNumAffected': 19, 'seriousNumAtRisk': 183, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'seriousEvents': [{'term': 'Chest Pain - Cardiac Cath to Rule Out Cad', 'notes': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Knee Pain Both Knees', 'notes': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Shoulder Pain (Index Shoulder) Right Shoulder', 'notes': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Breast Cancer', 'notes': 'Breast Cancer Female', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Patient has cancer, did not specify to PI where cancer is, never returned, lost to follow-up', 'notes': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Total Shoulder Arthroplasty Plus Bone Graft Glenoid Scapular Right Shoulder', 'notes': 'Shoulder Arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Left Shoulder Pain Non-Study Shoulder - Surgery 6/10/09', 'notes': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Quadruple Bypass 5/6/09', 'notes': 'Coronary artery bypass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Iliopsoas Abscess', 'notes': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Back Pain', 'notes': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Open Heart Surgery After Aortic Valve Disease', 'notes': 'Aortic valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Analog Scale (VAS) Pain Score (Per Protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'OG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}], 'classes': [{'categories': [{'measurements': [{'value': '30.389', 'spread': '3.035', 'groupId': 'OG000'}, {'value': '28.917', 'spread': '2.233', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.696', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.472', 'ciLowerLimit': '-8.888', 'ciUpperLimit': '5.943', 'pValueComment': 'The a priori threshold for significance was a two-sided p \\<0.05.', 'groupDescription': 'Anticipated VAS difference of 10 mm and SD of 25 mm indicated a sample size of 225 subjects in a 2:1 randomization would provide 80% power to detect a significant difference with a two-sided significance level of 5%. To account for a 15% dropout rate the sample size was increased to 270 subjects (180 Orthovisc, 90 control). The primary null hypothesis (Ho) no difference in VAS means at 6 months and the alternative hypothesis (Ha) was that Orthovisc (mean VAS) is superior to the control.', 'statisticalMethod': 'Mixed Models Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 Months', 'description': 'Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.', 'unitOfMeasure': 'mm on a 100 mm VAS scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (Per Protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'OG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}], 'classes': [{'categories': [{'measurements': [{'value': '63.8', 'groupId': 'OG000', 'lowerLimit': '50.1', 'upperLimit': '76.0'}, {'value': '63.6', 'groupId': 'OG001', 'lowerLimit': '53.7', 'upperLimit': '72.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-15.6', 'ciUpperLimit': '15.1', 'groupDescription': 'Asymptotic 95% confidence interval for the treatment group difference (Orthovisc - Control) in proportions of responders was calculated. The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups at 6 months is unequal.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 6 months', 'description': 'Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.\n\nA responder was defined as a 20 mm or greater reduction in VAS pain score from baseline to 6 months.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (As Treated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'OG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}], 'classes': [{'categories': [{'measurements': [{'value': '59.7', 'groupId': 'OG000', 'lowerLimit': '47.0', 'upperLimit': '71.5'}, {'value': '54.4', 'groupId': 'OG001', 'lowerLimit': '45.7', 'upperLimit': '63.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.3', 'ciLowerLimit': '-19.7', 'ciUpperLimit': '9.1', 'groupDescription': 'Asymptotic 95% confidence interval for the treatment group difference (Orthovisc - Control) in proportions of responders was calculated. The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups at 6 months is unequal.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 6 months', 'description': 'Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.\n\nA responder was defined as a 20 mm or greater reduction in VAS pain score from baseline to 6 months.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The As Treated analysis population included all subjects that received treatment and had outcome data.'}, {'type': 'SECONDARY', 'title': 'Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (Per Protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'OG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}], 'classes': [{'categories': [{'measurements': [{'value': '-23.624', 'spread': '3.206', 'groupId': 'OG000'}, {'value': '-24.494', 'spread': '2.356', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.827', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.870', 'ciLowerLimit': '-8.698', 'ciUpperLimit': '6.957', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \\<0.05.', 'groupDescription': 'The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.', 'statisticalMethod': 'Mixed Models Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The difference in pain was calculated as visit score - baseline score. Scores are measured on a 100 mm visual analogy scale.', 'unitOfMeasure': 'mm on a 100 mm VAS scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).'}, {'type': 'SECONDARY', 'title': 'Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (As Treated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'OG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}], 'classes': [{'categories': [{'measurements': [{'value': '-16.882', 'spread': '2.757', 'groupId': 'OG000'}, {'value': '-19.756', 'spread': '1.909', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.392', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.875', 'ciLowerLimit': '-9.472', 'ciUpperLimit': '3.723', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \\<0.05.', 'groupDescription': 'The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.', 'statisticalMethod': 'Mixed Models Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.\n\nThe difference in pain was calculated as visit score - baseline score.', 'unitOfMeasure': 'mm on a 100 mm VAS scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The As Treated analysis population included all subjects that received treatment and had outcome data.'}, {'type': 'SECONDARY', 'title': 'American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (Per Protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'OG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}], 'classes': [{'categories': [{'measurements': [{'value': '18.329', 'spread': '2.578', 'groupId': 'OG000'}, {'value': '17.397', 'spread': '1.917', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.772', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.932', 'ciLowerLimit': '-7.260', 'ciUpperLimit': '5.396', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \\<0.05.', 'groupDescription': 'The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.', 'statisticalMethod': 'Mixed Models Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.\n\nThe ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).'}, {'type': 'SECONDARY', 'title': 'American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (As Treated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'OG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}], 'classes': [{'categories': [{'measurements': [{'value': '12.960', 'spread': '2.197', 'groupId': 'OG000'}, {'value': '13.988', 'spread': '1.605', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.707', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.028', 'ciLowerLimit': '-4.338', 'ciUpperLimit': '6.393', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \\<0.05.', 'groupDescription': 'The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.', 'statisticalMethod': 'Mixed Models Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.\n\nThe ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The As Treated analysis population included all subjects that received treatment and had outcome data.'}, {'type': 'SECONDARY', 'title': 'American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (Per Protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'OG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}], 'classes': [{'categories': [{'measurements': [{'value': '18.228', 'spread': '2.438', 'groupId': 'OG000'}, {'value': '17.408', 'spread': '1.858', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.790', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.820', 'ciLowerLimit': '-6.866', 'ciUpperLimit': '5.227', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \\<0.05.', 'groupDescription': 'The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.', 'statisticalMethod': 'Mixed Models Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.\n\nThe ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.'}, {'type': 'SECONDARY', 'title': 'American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (As Treated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'OG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}], 'classes': [{'categories': [{'measurements': [{'value': '14.272', 'spread': '2.237', 'groupId': 'OG000'}, {'value': '15.402', 'spread': '1.636', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.685', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.130', 'ciLowerLimit': '-4.341', 'ciUpperLimit': '6.001', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \\<0.05.', 'groupDescription': 'The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.', 'statisticalMethod': 'Mixed Models Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.\n\nThe ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The As Treated analysis population included all subjects that received treatment and had outcome data.'}, {'type': 'SECONDARY', 'title': 'Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (Per Protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'OG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}], 'classes': [{'categories': [{'measurements': [{'value': '-17.871', 'spread': '2.477', 'groupId': 'OG000'}, {'value': '-10.554', 'spread': '1.830', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.317', 'ciLowerLimit': '1.249', 'ciUpperLimit': '13.386', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \\<0.05.', 'groupDescription': 'The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.', 'statisticalMethod': 'Mixed Models Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': "The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.\n\nThe Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.\n\nScoring instructions: The scores from both dimensions are averaged to derive a total score.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).'}, {'type': 'SECONDARY', 'title': 'Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (As Treated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'OG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}], 'classes': [{'categories': [{'measurements': [{'value': '-11.828', 'spread': '2.132', 'groupId': 'OG000'}, {'value': '-9.467', 'spread': '1.531', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.369', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.361', 'ciLowerLimit': '-2.801', 'ciUpperLimit': '7.522', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \\<0.05.', 'groupDescription': 'The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.', 'statisticalMethod': 'Mixed Models Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': "The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.\n\nThe Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.\n\nScoring instructions: The scores from both dimensions are averaged to derive a total score.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The As Treated analysis population included all subjects that received treatment and had outcome data.'}, {'type': 'PRIMARY', 'title': 'Visual Analog Scale (VAS) Pain Score (As Treated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'OG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}], 'classes': [{'categories': [{'measurements': [{'value': '33.196', 'spread': '2.777', 'groupId': 'OG000'}, {'value': '30.406', 'spread': '1.926', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.410', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.790', 'ciLowerLimit': '-9.441', 'ciUpperLimit': '3.861', 'pValueComment': 'The a priori threshold for significance was a two-sided p \\<0.05.', 'groupDescription': 'Anticipated VAS difference of 10 mm and SD of 25 mm indicated a sample size of 225 subjects in a 2:1 randomization would provide 80% power to detect a significant difference with a two-sided significance level of 5%. To account for a 15% dropout rate the sample size was increased to 270 subjects (180 Orthovisc, 90 control). The primary null hypothesis (Ho) no difference in VAS means at 6 months and the alternative hypothesis (Ha) was that Orthovisc (mean VAS) is superior to the control.', 'statisticalMethod': 'Mixed Models Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 Months', 'description': 'Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.', 'unitOfMeasure': 'mm on a 100 mm VAS scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The As Treated analysis population included all subjects that received treatment and had outcome data.'}, {'type': 'SECONDARY', 'title': 'Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (Per Protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'OG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}], 'classes': [{'categories': [{'measurements': [{'value': '-16.109', 'spread': '2.390', 'groupId': 'OG000'}, {'value': '-13.492', 'spread': '1.752', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.379', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.617', 'ciLowerLimit': '-3.226', 'ciUpperLimit': '8.460', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \\<0.05.', 'groupDescription': 'The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.', 'statisticalMethod': 'Mixed Models Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 6 months', 'description': "The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.\n\nThe Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.\n\nScoring instructions: The scores from both dimensions are averaged to derive a total score.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.'}, {'type': 'SECONDARY', 'title': 'Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (As Treated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'OG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}], 'classes': [{'categories': [{'measurements': [{'value': '-10.314', 'spread': '2.179', 'groupId': 'OG000'}, {'value': '-12.522', 'spread': '1.539', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.409', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.208', 'ciLowerLimit': '-7.455', 'ciUpperLimit': '3.039', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \\<0.05.', 'groupDescription': 'The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.', 'statisticalMethod': 'Mixed Models Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 6 months', 'description': "The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.\n\nThe Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.\n\nScoring instructions: The scores from both dimensions are averaged to derive a total score.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The As Treated analysis population included all subjects that received treatment and had outcome data.'}, {'type': 'SECONDARY', 'title': '12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (Per Protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'OG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}], 'classes': [{'categories': [{'measurements': [{'value': '3.607', 'spread': '1.050', 'groupId': 'OG000'}, {'value': '2.050', 'spread': '0.771', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.232', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.558', 'ciLowerLimit': '-4.119', 'ciUpperLimit': '1.003', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \\<0.05.', 'groupDescription': 'The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.', 'statisticalMethod': 'Mixed Models Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.\n\nThe SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.\n\nPhysical and Mental Health Composite Scores (PCS \\& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).'}, {'type': 'SECONDARY', 'title': '12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (As Treated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'OG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}], 'classes': [{'categories': [{'measurements': [{'value': '2.179', 'spread': '0.877', 'groupId': 'OG000'}, {'value': '1.950', 'spread': '0.624', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.832', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.228', 'ciLowerLimit': '-2.343', 'ciUpperLimit': '1.887', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \\<0.05.', 'groupDescription': 'The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.', 'statisticalMethod': 'Mixed Models Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.\n\nThe SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.\n\nPhysical and Mental Health Composite Scores (PCS \\& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The As Treated analysis population included all subjects that received treatment and had outcome data.'}, {'type': 'SECONDARY', 'title': '12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (Per Protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'OG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}], 'classes': [{'categories': [{'measurements': [{'value': '2.763', 'spread': '1.009', 'groupId': 'OG000'}, {'value': '2.831', 'spread': '0.743', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.957', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.068', 'ciLowerLimit': '-2.396', 'ciUpperLimit': '2.532', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \\<0.05.', 'groupDescription': 'The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.', 'statisticalMethod': 'Mixed Models Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.\n\nThe SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.\n\nPhysical and Mental Health Composite Scores (PCS \\& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.'}, {'type': 'SECONDARY', 'title': '12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (As Treated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'OG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}], 'classes': [{'categories': [{'measurements': [{'value': '1.559', 'spread': '0.896', 'groupId': 'OG000'}, {'value': '2.779', 'spread': '0.635', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.267', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.220', 'ciLowerLimit': '-0.937', 'ciUpperLimit': '3.378', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \\<0.05.', 'groupDescription': 'The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.', 'statisticalMethod': 'Mixed Models Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.\n\nThe SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.\n\nPhysical and Mental Health Composite Scores (PCS \\& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The As Treated analysis population included all subjects that received treatment and had outcome data.'}, {'type': 'SECONDARY', 'title': '12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (Per Protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'OG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.130', 'spread': '0.991', 'groupId': 'OG000'}, {'value': '1.060', 'spread': '0.726', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.333', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.190', 'ciLowerLimit': '-1.225', 'ciUpperLimit': '3.604', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \\<0.05.', 'groupDescription': 'The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.', 'statisticalMethod': 'Mixed Models Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.\n\nThe SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.\n\nPhysical and Mental Health Composite Scores (PCS \\& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).'}, {'type': 'SECONDARY', 'title': '12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (As Treated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'OG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}], 'classes': [{'categories': [{'measurements': [{'value': '0.167', 'spread': '0.875', 'groupId': 'OG000'}, {'value': '0.938', 'spread': '0.623', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.473', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.771', 'ciLowerLimit': '-1.339', 'ciUpperLimit': '2.881', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \\<0.05.', 'groupDescription': 'The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.', 'statisticalMethod': 'Mixed Models Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.\n\nThe SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.\n\nPhysical and Mental Health Composite Scores (PCS \\& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The As Treated analysis population included all subjects that received treatment and had outcome data.'}, {'type': 'SECONDARY', 'title': '12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (Per Protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'OG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}], 'classes': [{'categories': [{'measurements': [{'value': '0.397', 'spread': '0.941', 'groupId': 'OG000'}, {'value': '0.379', 'spread': '0.692', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.988', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.018', 'ciLowerLimit': '-2.314', 'ciUpperLimit': '2.278', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \\<0.05.', 'groupDescription': 'The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.', 'statisticalMethod': 'Mixed Models Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.\n\nThe SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.\n\nPhysical and Mental Health Composite Scores (PCS \\& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.'}, {'type': 'SECONDARY', 'title': '12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (As Treated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'OG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}], 'classes': [{'categories': [{'measurements': [{'value': '0.330', 'spread': '0.897', 'groupId': 'OG000'}, {'value': '0.798', 'spread': '0.636', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.671', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.467', 'ciLowerLimit': '-1.692', 'ciUpperLimit': '2.627', 'pValueComment': 'The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \\<0.05.', 'groupDescription': 'The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.', 'statisticalMethod': 'Mixed Models Repeated Measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.\n\nThe SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.\n\nPhysical and Mental Health Composite Scores (PCS \\& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The As Treated analysis population included all subjects that received treatment and had outcome data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'FG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '186'}]}, {'type': 'Randomized But Not Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '134'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '52'}]}]}], 'recruitmentDetails': 'Enrollment occurred between January 2007 and February 2010 at 13 sites based in the US.', 'preAssignmentDetails': 'Four subjects were randomized; however due to required imaging inclusion/exclusion criteria was not met. Hence, these 4 subjects were not treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).'}, {'id': 'BG001', 'title': 'Investigational', 'description': "Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.0', 'spread': '9.84', 'groupId': 'BG000'}, {'value': '58.6', 'spread': '10.68', 'groupId': 'BG001'}, {'value': '58.4', 'spread': '10.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18 to 29', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': '30 and 39 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': '40 to 49 years', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': '50 to 59 years', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}, {'title': '60 to 69 years', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}, {'title': '70 to 79 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The number of partipants analyzed were all 270 subjects that received treatment (87 control, 183 investigational).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 274}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2013-02-26', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-27', 'studyFirstSubmitDate': '2007-02-16', 'dispFirstSubmitQcDate': '2013-02-26', 'resultsFirstSubmitDate': '2013-08-13', 'studyFirstSubmitQcDate': '2007-02-16', 'dispFirstPostDateStruct': {'date': '2013-03-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-03-06', 'studyFirstPostDateStruct': {'date': '2007-02-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS) Pain Score (Per Protocol)', 'timeFrame': '6 Months', 'description': 'Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.'}, {'measure': 'Visual Analog Scale (VAS) Pain Score (As Treated)', 'timeFrame': '6 Months', 'description': 'Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (Per Protocol)', 'timeFrame': 'Baseline and 6 months', 'description': 'Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.\n\nA responder was defined as a 20 mm or greater reduction in VAS pain score from baseline to 6 months.'}, {'measure': 'Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (As Treated)', 'timeFrame': 'Baseline and 6 months', 'description': 'Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.\n\nA responder was defined as a 20 mm or greater reduction in VAS pain score from baseline to 6 months.'}, {'measure': 'Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (Per Protocol)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The difference in pain was calculated as visit score - baseline score. Scores are measured on a 100 mm visual analogy scale.'}, {'measure': 'Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (As Treated)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.\n\nThe difference in pain was calculated as visit score - baseline score.'}, {'measure': 'American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (Per Protocol)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.\n\nThe ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function.'}, {'measure': 'American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (As Treated)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.\n\nThe ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function.'}, {'measure': 'American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (Per Protocol)', 'timeFrame': 'Baseline and 6 months', 'description': 'The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.\n\nThe ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function.'}, {'measure': 'American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (As Treated)', 'timeFrame': 'Baseline and 6 months', 'description': 'The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.\n\nThe ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function.'}, {'measure': 'Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (Per Protocol)', 'timeFrame': 'Baseline and 12 weeks', 'description': "The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.\n\nThe Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.\n\nScoring instructions: The scores from both dimensions are averaged to derive a total score."}, {'measure': 'Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (As Treated)', 'timeFrame': 'Baseline and 12 weeks', 'description': "The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.\n\nThe Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.\n\nScoring instructions: The scores from both dimensions are averaged to derive a total score."}, {'measure': 'Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (Per Protocol)', 'timeFrame': 'Baseline and 6 months', 'description': "The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.\n\nThe Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.\n\nScoring instructions: The scores from both dimensions are averaged to derive a total score."}, {'measure': 'Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (As Treated)', 'timeFrame': 'Baseline and 6 months', 'description': "The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.\n\nThe Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.\n\nScoring instructions: The scores from both dimensions are averaged to derive a total score."}, {'measure': '12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (Per Protocol)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.\n\nThe SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.\n\nPhysical and Mental Health Composite Scores (PCS \\& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.'}, {'measure': '12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (As Treated)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.\n\nThe SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.\n\nPhysical and Mental Health Composite Scores (PCS \\& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.'}, {'measure': '12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (Per Protocol)', 'timeFrame': 'Baseline and 6 months', 'description': 'The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.\n\nThe SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.\n\nPhysical and Mental Health Composite Scores (PCS \\& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.'}, {'measure': '12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (As Treated)', 'timeFrame': 'Baseline and 6 months', 'description': 'The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.\n\nThe SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.\n\nPhysical and Mental Health Composite Scores (PCS \\& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.'}, {'measure': '12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (Per Protocol)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.\n\nThe SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.\n\nPhysical and Mental Health Composite Scores (PCS \\& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.'}, {'measure': '12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (As Treated)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.\n\nThe SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.\n\nPhysical and Mental Health Composite Scores (PCS \\& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.'}, {'measure': '12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (Per Protocol)', 'timeFrame': 'Baseline and 6 months', 'description': 'The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.\n\nThe SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.\n\nPhysical and Mental Health Composite Scores (PCS \\& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.'}, {'measure': '12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (As Treated)', 'timeFrame': 'Baseline and 6 months', 'description': 'The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.\n\nThe SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.\n\nPhysical and Mental Health Composite Scores (PCS \\& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Orthovisc', 'Osteoarthritis', 'Shoulder', 'Randomized'], 'conditions': ['Glenohumeral Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to osteoarthritis.', 'detailedDescription': 'This multicenter, prospective double-blinded, randomized trial will study two treatment groups. Subjects will be randomized to receive either Orthovisc or corticosteroids/anesthetic injection into the shoulder in a 2:1 schema. The trial will assess safety and efficacy of pain relief in the osteoarthritic shoulder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A candidate for unilateral treatment of osteoarthritis of the shoulder\n* Have failed conservative treatment\n\nExclusion Criteria:\n\n* Presence of full thickness Rotator Cuff tear and/or significantly compromised rotator cuff function\n* No active instability or acute dislocation episodes within the previous 12 months\n* Known allergy to hyaluronate preparations\n* Pregnant or breast feeding\n* Is receiving prescription pain medication for conditions unrelated to the index shoulder condition'}, 'identificationModule': {'nctId': 'NCT00436969', 'briefTitle': 'ORTHOVISC Shoulder Osteoarthritis Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'DePuy Mitek'}, 'officialTitle': 'A Comparison of Orthovisc® to Corticosteroid Injection in Shoulder Osteoarthritis: Orthovisc Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '06-OV-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': "Subjects randomized to the control arm injection of prescribed anesthetic and corticosteroid, shall receive an equivalent volume (8 mL's).", 'interventionNames': ['Drug: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Investigational', 'description': "Subjects randomized to the active treatment in this study will receive a one-time dose of 8 mL's of Orthovisc derived from non-animal source bacterial fermentation, S. Equi.", 'interventionNames': ['Device: Orthovisc']}], 'interventions': [{'name': 'Orthovisc', 'type': 'DEVICE', 'otherNames': ['Hyaluronic acid'], 'description': 'Orthovisc injection', 'armGroupLabels': ['Investigational']}, {'name': 'Control', 'type': 'DRUG', 'otherNames': ['Corticosteroid'], 'description': 'Celestone (betamethasone sodium phosphate and acetate) - 2 mL', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'CORE Orthopedics', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Sierra Pacific Orthopaedic Center Medical Group', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'UHZ Sports Medicine', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '32561', 'city': 'Gulf Breeze', 'state': 'Florida', 'country': 'United States', 'facility': 'Andrews Research Institute', 'geoPoint': {'lat': 30.35714, 'lon': -87.16386}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Clinic Foundation', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '01605', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Merdical School - Worcester', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48081', 'city': 'Saint Clair Shores', 'state': 'Michigan', 'country': 'United States', 'facility': 'Shores Rheumatology', 'geoPoint': {'lat': 42.49698, 'lon': -82.88881}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Insall Scott Kelly Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '74146', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Tulsa Bone and Joint', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '16801', 'city': 'State College', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University Orthopedics Center', 'geoPoint': {'lat': 40.79339, 'lon': -77.86}}, {'zip': '11030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Methodist', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '98431', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Madigan Army Medical Center', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'Jonathan B. McGlohorn', 'role': 'STUDY_DIRECTOR', 'affiliation': 'DePuy Synthes Mitek and Biomaterials'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We will not submit the data to FDA, and as such will not be making IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DePuy Mitek', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}