Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-11 @ 7:35 AM
Study NCT ID:
NCT02493660
Status:
COMPLETED
Last Update Posted:
2022-06-15
First Post:
2015-07-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'colleen.roden@stryker.com', 'phone': '1 931 267 2041', 'title': 'Colleen Roden, Director, Clinical Operations', 'organization': 'Stryker Company'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of 45 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and can only extend the embargo with patent protection review.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Collected over 12 months and 24 months visit.', 'description': 'The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.', 'eventGroups': [{'id': 'EG000', 'title': 'InSpace Implantation', 'description': 'Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation\n\nInSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system', 'otherNumAtRisk': 93, 'deathsNumAtRisk': 93, 'otherNumAffected': 67, 'seriousNumAtRisk': 93, 'deathsNumAffected': 0, 'seriousNumAffected': 22}, {'id': 'EG001', 'title': 'Tendon Repair', 'description': 'Arthroscopic partial repair of rotator cuff\n\nPartial repair of rotator cuff: Arthroscopic partial repair of rotator cuff', 'otherNumAtRisk': 91, 'deathsNumAtRisk': 91, 'otherNumAffected': 69, 'seriousNumAtRisk': 91, 'deathsNumAffected': 1, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Musculoskeletal pain, Arthralgia, back pain (anywhere in body)', 'notes': 'Note: One subject may have more than one event in all of these categories.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 96, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 71, 'numAffected': 48}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}, {'term': 'Fall and injury, meniscus injury, Tendon rupture (anywhere in body)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 23, 'numAffected': 22}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}, {'term': 'UTI, Bronchitis, pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 23, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}, {'term': 'Headache, dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}, {'term': 'Pain, Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}, {'term': 'Atrial fibrillation', 'notes': 'Note: Some subjects may have more than one event.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}, {'term': 'Pre-Ventricular Contractions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}], 'seriousEvents': [{'term': 'eg. Pain or inflammation', 'notes': 'All body areas reported', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}, {'term': 'eg. dizziness, Aphasia, Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}, {'term': 'eg.Prostate cancer, leukemia, Parathyroid tumor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}, {'term': 'eg. Multi-vessel Coronary Artery Disease', 'notes': 'Same subject can have more than one event.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}, {'term': 'eg.Laryngeal granuloma, Chronic obstructive pulmonary disease, pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}, {'term': 'eg. Gastrointestinal haemorrhage, short-bowel syndrome, small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}, {'term': 'eg. Event leading to Death, non-cardiac chest pain, surgical failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}, {'term': 'Angina Pectoris (Chest pain-Cardiac)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}, {'term': 'Atrial Fibrillation', 'notes': 'Same subject can have more than one event.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}, {'term': 'Cardiac Arrest', 'notes': 'Same subject can have more than one event.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants in the Per Protocol Population With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears From Baseline to Month 12 With no SSSIs and no SADEs.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InSpace Implantation', 'description': 'InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system'}, {'id': 'OG001', 'title': 'Tendon Repair', 'description': 'Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff'}], 'classes': [{'categories': [{'measurements': [{'value': '51.1', 'groupId': 'OG000'}, {'value': '39.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0049', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Primary analysis method was for month 12 success with age (\\<65 years, ≥65 years), sex, and treatment as the model covariates.', 'nonInferiorityComment': 'The non-inferiority margin was 10% for all composite endpoints. The primary analysis method was a multilinear regression model for month 12 success with age (\\<65 years, ≥65 years), gender, and treatment as the model covariates for the PP population for noninferiority testing.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to month 12', 'description': 'The primary composite effectiveness endpoint was defined as achievement of improvement for the Western Ontario Rotator Cuff (WORC) score (≥275 points) and American Shoulder and Elbow Society (ASES) score (≥6.4 points) by week 6 and maintenance at month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs).\n\nThe improvement of points of the Western Ontario Rotator Cuff (WORC) of at least 275 (point scale of 0-2100:lower score is better) and American Shoulder and Elbow Society (ASES) at least 6.4 (point scale of 0-100:higher score is better) reflect the required number of points in improvement for treatment to be considered successful.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentage of participants in the Per Protocol Population (PP) with surgical treatment success of the InSpace device as a Primary surgical treatment for Full-thickness massive rotator cuff tears (MRCT).'}, {'type': 'SECONDARY', 'title': 'Composite Endpoint of WORC Improvement ≥275 and ASES Improvement ≥6.4 at Week 6 Maintained at Month 24 no Subsequent Secondary Surgical Intervention (SSSI) and no Serious Adverse Device Effect (SADEs) (Pre-specified). Composite WORC ASES and Safety to M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InSpace Implantation', 'description': 'Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation\n\nInSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system'}, {'id': 'OG001', 'title': 'Tendon Repair', 'description': 'Arthroscopic partial repair of rotator cuff\n\nPartial repair of rotator cuff: Arthroscopic partial repair of rotator cuff'}], 'classes': [{'categories': [{'measurements': [{'value': '46.3', 'groupId': 'OG000', 'lowerLimit': '35.5', 'upperLimit': '57.1'}, {'value': '38.0', 'groupId': 'OG001', 'lowerLimit': '27.0', 'upperLimit': '49.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through to Month 24', 'description': 'Composite Endpoint Per Protocol Population (PP) of WORC Improvement ≥ 275 and ASES Improvement ≥ 6.4 from baseline at Week 6 Maintained at Month 24 with no Subsequent Secondary Surgical Intervention (SSSI) and no Serious Adverse Device Effect (SADEs) (pre-specified).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population with no major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Composite Endpoint Component Level Success for WORC at Month 12 Compared to Baseline in the Per Protocol Population (PP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InSpace Implantation', 'description': 'InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system'}, {'id': 'OG001', 'title': 'Tendon Repair', 'description': 'Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff'}], 'classes': [{'categories': [{'measurements': [{'value': '89.8', 'groupId': 'OG000'}, {'value': '87.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to month 12', 'description': 'The secondary effectiveness endpoint was defined as a composite component-level success at Month 12 for Western Ontario Rotator Cuff (WORC) total score improvement (≥275) (scale of 0-2100:lower score is better) in the two groups, InSpace and Partial Repair without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population'}, {'type': 'SECONDARY', 'title': 'Composite Endpoint Component Level Success for ASES at Month 12 Compared to Baseline in the Per Protocol Population (PP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InSpace Implantation', 'description': 'InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system'}, {'id': 'OG001', 'title': 'Tendon Repair', 'description': 'Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff'}], 'classes': [{'categories': [{'measurements': [{'value': '96.3', 'groupId': 'OG000'}, {'value': '90.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Results from logistic regression model.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority margin was 10% for all composite endpoints.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to month 12', 'description': 'The secondary endpoint was defined as a composite component-level success for American Shoulder and Elbow Surgeons ( ASES) compared at baseline to Month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs)..\n\nThe total score improvement of (≥ 6.4 points) (scale of 0-100:higher score is better) from baseline in the two groups, InSpace and Partial Repair.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. WORC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InSpace Implantation', 'description': 'InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system'}, {'id': 'OG001', 'title': 'Tendon Repair', 'description': 'Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff'}], 'classes': [{'categories': [{'measurements': [{'value': '-1083.37', 'groupId': 'OG000', 'lowerLimit': '-1199.94', 'upperLimit': '-966.81'}, {'value': '-1007.00', 'groupId': 'OG001', 'lowerLimit': '-1108.34', 'upperLimit': '-905.67'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through to month 24', 'description': 'The secondary effectiveness endpoint was defined as mean change from baseline to Month 24 for Western Ontario Rotator Cuff (WORC) total score improvement (≥275) (scale of 0-2100:lower score is better) in the two groups, InSpace and Partial Repair.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent To Treat (ITT) population with available data.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. ASES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InSpace Implantation', 'description': 'InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system'}, {'id': 'OG001', 'title': 'Tendon Repair', 'description': 'Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff'}], 'classes': [{'categories': [{'measurements': [{'value': '46.22', 'groupId': 'OG000', 'lowerLimit': '41.66', 'upperLimit': '50.79'}, {'value': '42.53', 'groupId': 'OG001', 'lowerLimit': '37.96', 'upperLimit': '47.10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through to month 24', 'description': 'Mean change in American Shoulder and Elbow Surgeons (ASES) score from baseline to month 24.\n\nThe improvement of points of the American Shoulder and Elbow Society (ASES) at least 6.4 (point scale of 0-100:higher score is better) reflect the required number of points in improvement for treatment to be considered successful.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent To Treat (ITT) Population with available data'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Month 24 for Constant-Murley (CS) in the Intent To Treat Population (ITT) With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InSpace Implantation', 'description': 'Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation\n\nInSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system'}, {'id': 'OG001', 'title': 'Tendon Repair', 'description': 'Arthroscopic partial repair of rotator cuff\n\nPartial repair of rotator cuff: Arthroscopic partial repair of rotator cuff'}], 'classes': [{'categories': [{'measurements': [{'value': '28.22', 'groupId': 'OG000', 'lowerLimit': '23.92', 'upperLimit': '32.51'}, {'value': '21.81', 'groupId': 'OG001', 'lowerLimit': '16.99', 'upperLimit': '26.63'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to month 24', 'description': 'The secondary effectiveness endpoint was defined as mean change from baseline to Month 24 for Constant-Murley (CS) Shoulder Outcome score (where the scale of 0-100:higher score is better) in the two groups, InSpace and Partial Repair.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) Population with available data'}, {'type': 'SECONDARY', 'title': 'The Mean Change From Baseline to Month 24 for EQ-5D-5L for Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InSpace Implantation', 'description': 'Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation\n\nInSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system'}, {'id': 'OG001', 'title': 'Tendon Repair', 'description': 'Arthroscopic partial repair of rotator cuff\n\nPartial repair of rotator cuff: Arthroscopic partial repair of rotator cuff'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.65', 'groupId': 'OG000', 'lowerLimit': '-5.36', 'upperLimit': '-3.94'}, {'value': '-4.00', 'groupId': 'OG001', 'lowerLimit': '-4.61', 'upperLimit': '-3.39'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through to month 24', 'description': 'The secondary effectiveness endpoint was defined as change in baseline to Month 24 for Quality of Life (EQ-5D-5L) (scale of 0-100: lower score better) in the two groups, InSpace and Partial Repair.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) Population with available data'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Month 24 for VAS in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InSpace Implantation', 'description': 'Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation\n\nInSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system'}, {'id': 'OG001', 'title': 'Tendon Repair', 'description': 'Arthroscopic partial repair of rotator cuff\n\nPartial repair of rotator cuff: Arthroscopic partial repair of rotator cuff'}], 'classes': [{'categories': [{'measurements': [{'value': '-56.55', 'groupId': 'OG000', 'lowerLimit': '-61.78', 'upperLimit': '-51.32'}, {'value': '-54.55', 'groupId': 'OG001', 'lowerLimit': '-59.92', 'upperLimit': '-49.19'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through to month 24', 'description': 'The secondary effectiveness endpoint was defined as the mean change from baseline at Month 24 for Visual Analogue Scale (VAS) (scale of 0-100:lower score is better) in the two groups, InSpace and Partial Repair.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent To Treat (ITT) Population with available data'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Month 24 for ASES ROM in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InSpace Implantation', 'description': 'Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation\n\nInSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system'}, {'id': 'OG001', 'title': 'Tendon Repair', 'description': 'Arthroscopic partial repair of rotator cuff\n\nPartial repair of rotator cuff: Arthroscopic partial repair of rotator cuff'}], 'classes': [{'categories': [{'measurements': [{'value': '36.89', 'groupId': 'OG000', 'lowerLimit': '28.02', 'upperLimit': '45.76'}, {'value': '18.16', 'groupId': 'OG001', 'lowerLimit': '9.33', 'upperLimit': '26.98'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through to month 24', 'description': 'The secondary effectiveness endpoint was defined as mean change from baseline at Month 24 for American Shoulder and Elbow Surgeons (ASES) range of motion (ROM)-physician reported portion. (scale of 0-180 Degrees: higher score is better) in the two groups, InSpace and Partial Repair.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) Population with available data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'InSpace Implantation', 'description': 'Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation\n\nInSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system'}, {'id': 'FG001', 'title': 'Tendon Repair', 'description': 'Arthroscopic partial repair of rotator cuff\n\nPartial repair of rotator cuff: Arthroscopic partial repair of rotator cuff'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'ITT', 'groupId': 'FG000', 'numSubjects': '93'}, {'comment': 'ITT', 'groupId': 'FG001', 'numSubjects': '91'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'comment': 'Investigator requested subject be discontinued prior to any post-procedure efficacy assessments.', 'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Subject unable to return for follow-up visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Subjects assessed for eligibility n=229', 'preAssignmentDetails': 'Subjects excluded (n=45) for various reasons, not meeting criteria (n=11), declined to participate (n=12), and Other (n=22) such as, no medical clearance for surgery, intra-op screen failures, enrollment full.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'InSpace Implantation', 'description': 'Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation\n\nInSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system'}, {'id': 'BG001', 'title': 'Tendon Repair', 'description': 'Arthroscopic partial repair of rotator cuff\n\nPartial repair of rotator cuff: Arthroscopic partial repair of rotator cuff'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.8', 'spread': '7.70', 'groupId': 'BG000'}, {'value': '64.7', 'spread': '7.88', 'groupId': 'BG001'}, {'value': '65.8', 'spread': '7.84', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Number of subjects who were randomized and received an InSpace implant and the number of subjects who received a Partial Repair of their rotator cuff.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-26', 'size': 1316690, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-19T08:55', 'hasProtocol': True}, {'date': '2018-03-26', 'size': 207165, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-05-11T15:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 184}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-14', 'studyFirstSubmitDate': '2015-07-01', 'resultsFirstSubmitDate': '2021-05-19', 'studyFirstSubmitQcDate': '2015-07-06', 'lastUpdatePostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-30', 'studyFirstPostDateStruct': {'date': '2015-07-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants in the Per Protocol Population With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears From Baseline to Month 12 With no SSSIs and no SADEs.', 'timeFrame': 'Baseline to month 12', 'description': 'The primary composite effectiveness endpoint was defined as achievement of improvement for the Western Ontario Rotator Cuff (WORC) score (≥275 points) and American Shoulder and Elbow Society (ASES) score (≥6.4 points) by week 6 and maintenance at month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs).\n\nThe improvement of points of the Western Ontario Rotator Cuff (WORC) of at least 275 (point scale of 0-2100:lower score is better) and American Shoulder and Elbow Society (ASES) at least 6.4 (point scale of 0-100:higher score is better) reflect the required number of points in improvement for treatment to be considered successful.'}], 'secondaryOutcomes': [{'measure': 'Composite Endpoint of WORC Improvement ≥275 and ASES Improvement ≥6.4 at Week 6 Maintained at Month 24 no Subsequent Secondary Surgical Intervention (SSSI) and no Serious Adverse Device Effect (SADEs) (Pre-specified). Composite WORC ASES and Safety to M24', 'timeFrame': 'Baseline through to Month 24', 'description': 'Composite Endpoint Per Protocol Population (PP) of WORC Improvement ≥ 275 and ASES Improvement ≥ 6.4 from baseline at Week 6 Maintained at Month 24 with no Subsequent Secondary Surgical Intervention (SSSI) and no Serious Adverse Device Effect (SADEs) (pre-specified).'}, {'measure': 'Composite Endpoint Component Level Success for WORC at Month 12 Compared to Baseline in the Per Protocol Population (PP)', 'timeFrame': 'Baseline to month 12', 'description': 'The secondary effectiveness endpoint was defined as a composite component-level success at Month 12 for Western Ontario Rotator Cuff (WORC) total score improvement (≥275) (scale of 0-2100:lower score is better) in the two groups, InSpace and Partial Repair without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs).'}, {'measure': 'Composite Endpoint Component Level Success for ASES at Month 12 Compared to Baseline in the Per Protocol Population (PP)', 'timeFrame': 'Baseline to month 12', 'description': 'The secondary endpoint was defined as a composite component-level success for American Shoulder and Elbow Surgeons ( ASES) compared at baseline to Month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs)..\n\nThe total score improvement of (≥ 6.4 points) (scale of 0-100:higher score is better) from baseline in the two groups, InSpace and Partial Repair.'}, {'measure': 'Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. WORC', 'timeFrame': 'Baseline through to month 24', 'description': 'The secondary effectiveness endpoint was defined as mean change from baseline to Month 24 for Western Ontario Rotator Cuff (WORC) total score improvement (≥275) (scale of 0-2100:lower score is better) in the two groups, InSpace and Partial Repair.'}, {'measure': 'Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. ASES', 'timeFrame': 'Baseline through to month 24', 'description': 'Mean change in American Shoulder and Elbow Surgeons (ASES) score from baseline to month 24.\n\nThe improvement of points of the American Shoulder and Elbow Society (ASES) at least 6.4 (point scale of 0-100:higher score is better) reflect the required number of points in improvement for treatment to be considered successful.'}, {'measure': 'Mean Change From Baseline to Month 24 for Constant-Murley (CS) in the Intent To Treat Population (ITT) With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears', 'timeFrame': 'Baseline to month 24', 'description': 'The secondary effectiveness endpoint was defined as mean change from baseline to Month 24 for Constant-Murley (CS) Shoulder Outcome score (where the scale of 0-100:higher score is better) in the two groups, InSpace and Partial Repair.'}, {'measure': 'The Mean Change From Baseline to Month 24 for EQ-5D-5L for Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears', 'timeFrame': 'Baseline through to month 24', 'description': 'The secondary effectiveness endpoint was defined as change in baseline to Month 24 for Quality of Life (EQ-5D-5L) (scale of 0-100: lower score better) in the two groups, InSpace and Partial Repair.'}, {'measure': 'Mean Change From Baseline to Month 24 for VAS in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears', 'timeFrame': 'Baseline through to month 24', 'description': 'The secondary effectiveness endpoint was defined as the mean change from baseline at Month 24 for Visual Analogue Scale (VAS) (scale of 0-100:lower score is better) in the two groups, InSpace and Partial Repair.'}, {'measure': 'Mean Change From Baseline to Month 24 for ASES ROM in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears', 'timeFrame': 'Baseline through to month 24', 'description': 'The secondary effectiveness endpoint was defined as mean change from baseline at Month 24 for American Shoulder and Elbow Surgeons (ASES) range of motion (ROM)-physician reported portion. (scale of 0-180 Degrees: higher score is better) in the two groups, InSpace and Partial Repair.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Massive Rotator Cuff Tear', 'Arthroscopy', 'Shoulder Joint', 'Rotator cuff partial repair'], 'conditions': ['Rotator Cuff Syndrome']}, 'descriptionModule': {'briefSummary': 'A pivotal study to assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical partial repair of full thickness Massive Rotator Cuff Tear (MRCT).', 'detailedDescription': 'This is a non-inferiority, prospective, single blinded, multi-center, randomized, controlled, pivotal study evaluating the safety and effectiveness of the InSpace™ device as a primary surgical treatment for full thickness MRCT in comparison to Partial Repair of a full thickness MRCT performed during an arthroscopic procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Main Inclusion Criteria:\n\n* Positive diagnostic imaging by MRI of the index shoulder indicating a full thickness Massive Rotator Cuff Tear (MRCT), measuring ≥ 5 cm in diameter involving ≥ two tendons (confirmed Intra-operatively)\n* Functional deltoid muscle and preserved passive range of motion on physical examination\n* Documented VAS score of \\> 30 mm pain\n* Failed non-operative treatment of at least 4 months\n* Patient in general good health,independent, and can comply with all post-operative evaluations and visits.\n\nMain Exclusion Criteria:\n\n* Known allergy to the device material (copolymer of PLA and -ε-caprolactone)\n* Evidence of the following conditions:\n\n 1. significant gleno-humeral or acromiohumeral arthritis\n 2. full thickness cartilage loss as seen on MRI\n 3. gleno-humeral instability (excessive translation of the humeral head on the glenoid fossa)\n 4. pre-existing deltoid defect or deltoid palsy\n 5. major joint trauma, infection or necrosis\n 6. partial thickness tears of the supraspinatous\n 7. fully reparable rotator cuff tear \\[Tear of less than 5 cm in diameter (or \\< 4 cm2) with retractable tendon that can be fully repaired\\]\n* The subject requires concomitant subscapularis repair and/or labral repair\n* Previous surgery of the index shoulder in the past 1 year, excluding diagnostic arthroscopy\n* The subject's condition is bilateral and rotator cuff repair is scheduled or to be scheduled over the course of this study for the contra lateral shoulder\n* Major medical condition that could affect quality of life and influence the results of the study (e.g. HIV or other immunosuppressive conditions, active malignancy in the past 5 years, acute MI, CVA, etc.)\n* Documented evidence of a history of drug/alcohol abuse within 12 months of enrollment\n* The subject's condition represents a worker's compensation case\n* The subject is currently involved in a health-related litigation procedure\n* Females of child-bearing potential who are pregnant or breastfeeding or plan to become pregnant during the course of the study\n* Concurrent participation in any other investigational clinical study one month prior to enrollment or during the entire study period\n* The subject has implanted metallic devices (e.g., cardiac pacemakers, insulin pumps, nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing a MRI scan or has claustrophobia that would inhibit ability to undergo a MRI scan .\n* The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant to follow-up\n* The subject is receiving prescription narcotic pain medication for conditions unrelated to the index shoulder condition\n* The subject currently has an acute infection in the area surrounding the surgical site."}, 'identificationModule': {'nctId': 'NCT02493660', 'briefTitle': 'A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears', 'organization': {'class': 'INDUSTRY', 'fullName': 'OrthoSpace Ltd.'}, 'officialTitle': 'A Prospective, Single Blinded, Multi-center, Randomized, Controlled, Pivotal Study to Assess the Safety and Effectiveness of the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears', 'orgStudyIdInfo': {'id': 'CLD-OR-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'InSpace implantation', 'description': 'Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation', 'interventionNames': ['Device: InSpace sub-acromial tissue spacer system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tendon Repair', 'description': 'Arthroscopic partial repair of rotator cuff', 'interventionNames': ['Procedure: Partial repair of rotator cuff']}], 'interventions': [{'name': 'InSpace sub-acromial tissue spacer system', 'type': 'DEVICE', 'description': 'Arthroscopic implantation of InSpace sub-acromial tissue spacer system', 'armGroupLabels': ['InSpace implantation']}, {'name': 'Partial repair of rotator cuff', 'type': 'PROCEDURE', 'description': 'Arthroscopic partial repair of rotator cuff', 'armGroupLabels': ['Tendon Repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91405', 'city': 'Van Nuys', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Orthopedic Institute', 'geoPoint': {'lat': 34.18667, 'lon': -118.44897}}, {'zip': '80222', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33334', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Holy Cross Hospital', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Midwest Orthopedics at RUSH', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '51107', 'city': 'Rockford', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rockford Orthopedic Associates', 'geoPoint': {'lat': 42.27113, 'lon': -89.094}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University School of Medicine', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21205-1911', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'MedStar Union Memorial Orthopaedics', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02166', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham & Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14260', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'University of Buffalo Buffalo', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '13057', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Upstate Orthopedics', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '45209', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati SportsMedicine and Orthopaedic Center - Mercy Health', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43210', 'city': 'Ohio City', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 41.48422, 'lon': -81.71124}}, {'zip': '19152', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rothman Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '16801', 'city': 'State College', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University Orthopedic Center', 'geoPoint': {'lat': 40.79339, 'lon': -77.86}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Fowler Kennedy Sport Medicine Clinic', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Roth McFarlane Hand and Upper Limb Center', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Hospital Research Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Assaf Dekel, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ortho-Space'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OrthoSpace Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}