Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-02-22 @ 9:04 AM
Study NCT ID:
NCT02762903
Status:
COMPLETED
Last Update Posted:
2024-08-06
First Post:
2016-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lesser Tuberosity Osteotomy for Subscapularis Repair
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': 'C481298', 'term': 'theasinensin A'}, {'id': 'D000072227', 'term': 'Shoulder Prosthesis'}], 'ancestors': [{'id': 'D007595', 'term': 'Joint Prosthesis'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wnl1@cumc.columbia.edu', 'phone': '212-305-0998', 'title': 'William N. Levine, MD', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The standard deviation for Outcome Measure #2,4,5 was not calculated. Raw data existed during the study period of 2009 to 2013. This record was completed and published in 2016 without results. The data was subsequently destroyed because the data retention period had ended. This study closed with the IRB in 2017 and further analysis cannot be conducted. As of the current year, 2024, all the raw data for this study no longer exists. The standard deviation cannot be calculated without the raw data.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 1 year after surgery.', 'eventGroups': [{'id': 'EG000', 'title': 'Tenotomy', 'description': 'Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique.\n\nTSA with tenotomy technique: Standard procedure: Utilization of tenotomy for mobilization of subscapularis during total shoulder arthroplasty (TSA). The subscapularis tendon is incised close to its attachment on the humerus. The Tendon is repaired with sutures.\n\nShoulder prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 2, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Osteotomy', 'description': 'Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique.\n\nTSA with lesser tuberosity osteotomy technique: Standard procedure: Utilization of the osteotomy to mobilize the subscapularis during TSA. A small fleck of bone is removed from humerus, the subscapularis tendon is still attached. The fleck of bone is reattached with sutures.\n\nShoulder prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 5, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Tear of Supraspinatus', 'notes': 'Partial-thickness, bursal-sided tear of the supraspinatus managed nonoperatively.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Subacromial impingement', 'notes': 'Subacromial impingement requiring arthroscopic bursectomy and anterior acromioplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'notes': 'Pain developed at 3 months postoperatively owing to a loose cerclage wire, requiring hardware removal and lysis of adhesions.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient post-operative radial nerve palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Subacromial bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Trapezius spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Radiologic Evidence of Anatomic Healing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenotomy', 'description': 'Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique.\n\nTSA with tenotomy technique: Standard procedure: Utilization of tenotomy for mobilization of subscapularis during total shoulder arthroplasty (TSA). The subscapularis tendon is incised close to its attachment on the humerus. The Tendon is repaired with sutures.\n\nShoulder prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.'}, {'id': 'OG001', 'title': 'Osteotomy', 'description': 'Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique.\n\nTSA with lesser tuberosity osteotomy technique: Standard procedure: Utilization of the osteotomy to mobilize the subscapularis during TSA. A small fleck of bone is removed from humerus, the subscapularis tendon is still attached. The fleck of bone is reattached with sutures.\n\nShoulder prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post operative at 1 year', 'description': 'Tendon healing/tuberosity union based on radiographs', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only includes participants who completed the final follow-up.'}, {'type': 'SECONDARY', 'title': 'Mean Visual Analogue Pain Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenotomy', 'description': 'Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique.\n\nTSA with tenotomy technique: Standard procedure: Utilization of tenotomy for mobilization of subscapularis during total shoulder arthroplasty (TSA). The subscapularis tendon is incised close to its attachment on the humerus. The Tendon is repaired with sutures.\n\nShoulder prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.'}, {'id': 'OG001', 'title': 'Osteotomy', 'description': 'Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique.\n\nTSA with lesser tuberosity osteotomy technique: Standard procedure: Utilization of the osteotomy to mobilize the subscapularis during TSA. A small fleck of bone is removed from humerus, the subscapularis tendon is still attached. The fleck of bone is reattached with sutures.\n\nShoulder prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': 'NA', 'comment': 'The standard deviation was not calculated. Raw data existed during the study period of 2009 to 2013. This record was completed and published in 2016 without results. The data was subsequently destroyed because the data retention period had ended. This study closed with the IRB in 2017 and further analysis cannot be conducted. As of the current year, 2024, all the raw data for this study no longer exists. The standard deviation cannot be calculated without the raw data.', 'groupId': 'OG000'}, {'value': '1.8', 'spread': 'NA', 'comment': 'The standard deviation was not calculated. Raw data existed during the study period of 2009 to 2013. This record was completed and published in 2016 without results. The data was subsequently destroyed because the data retention period had ended. This study closed with the IRB in 2017 and further analysis cannot be conducted. As of the current year, 2024, all the raw data for this study no longer exists. The standard deviation cannot be calculated without the raw data.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year post-operatively', 'description': 'Pain indication measurement where 0 indicates no pain and 10 indicates worst possible pain. Mean score is reported without a range or standard deviation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only includes participants who completed the final follow-up.'}, {'type': 'SECONDARY', 'title': 'Forward Elevation (FE) Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenotomy', 'description': 'Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique.\n\nTSA with tenotomy technique: Standard procedure: Utilization of tenotomy for mobilization of subscapularis during total shoulder arthroplasty (TSA). The subscapularis tendon is incised close to its attachment on the humerus. The Tendon is repaired with sutures.\n\nShoulder prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.'}, {'id': 'OG001', 'title': 'Osteotomy', 'description': 'Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique.\n\nTSA with lesser tuberosity osteotomy technique: Standard procedure: Utilization of the osteotomy to mobilize the subscapularis during TSA. A small fleck of bone is removed from humerus, the subscapularis tendon is still attached. The fleck of bone is reattached with sutures.\n\nShoulder prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.'}], 'classes': [{'categories': [{'measurements': [{'value': '153', 'spread': '7', 'groupId': 'OG000'}, {'value': '150', 'spread': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year post-operatively', 'description': 'Strength testing with Dynamometer in forward elevation was conducted to determine the mean in FE strength.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only includes participants who completed the final follow-up.'}, {'type': 'SECONDARY', 'title': 'Total Intra-Operative Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenotomy', 'description': 'Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique.\n\nTSA with tenotomy technique: Standard procedure: Utilization of tenotomy for mobilization of subscapularis during total shoulder arthroplasty (TSA). The subscapularis tendon is incised close to its attachment on the humerus. The Tendon is repaired with sutures.\n\nShoulder prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.'}, {'id': 'OG001', 'title': 'Osteotomy', 'description': 'Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique.\n\nTSA with lesser tuberosity osteotomy technique: Standard procedure: Utilization of the osteotomy to mobilize the subscapularis during TSA. A small fleck of bone is removed from humerus, the subscapularis tendon is still attached. The fleck of bone is reattached with sutures.\n\nShoulder prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.'}], 'classes': [{'categories': [{'measurements': [{'value': '129.3', 'spread': 'NA', 'comment': 'The standard deviation was not calculated. Raw data existed during the study period of 2009 to 2013. This record was completed and published in 2016 without results. The data was subsequently destroyed because the data retention period had ended. This study closed with the IRB in 2017 and further analysis cannot be conducted. As of the current year, 2024, all the raw data for this study no longer exists. The standard deviation cannot be calculated without the raw data.', 'groupId': 'OG000'}, {'value': '152.7', 'spread': 'NA', 'comment': 'The standard deviation was not calculated. Raw data existed during the study period of 2009 to 2013. This record was completed and published in 2016 without results. The data was subsequently destroyed because the data retention period had ended. This study closed with the IRB in 2017 and further analysis cannot be conducted. As of the current year, 2024, all the raw data for this study no longer exists. The standard deviation cannot be calculated without the raw data.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From incision time to time of complete skin closure', 'description': 'To be recorded in minutes, and documented by the surgical team', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only includes participants who completed the final follow-up.'}, {'type': 'SECONDARY', 'title': 'Total Subscapularis Repair Time (in Minutes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenotomy', 'description': 'Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique.\n\nTSA with tenotomy technique: Standard procedure: Utilization of tenotomy for mobilization of subscapularis during total shoulder arthroplasty (TSA). The subscapularis tendon is incised close to its attachment on the humerus. The Tendon is repaired with sutures.\n\nShoulder prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.'}, {'id': 'OG001', 'title': 'Osteotomy', 'description': 'Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique.\n\nTSA with lesser tuberosity osteotomy technique: Standard procedure: Utilization of the osteotomy to mobilize the subscapularis during TSA. A small fleck of bone is removed from humerus, the subscapularis tendon is still attached. The fleck of bone is reattached with sutures.\n\nShoulder prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.3', 'spread': 'NA', 'comment': 'The standard deviation was not calculated. Raw data existed during the study period of 2009 to 2013. This record was completed and published in 2016 without results. The data was subsequently destroyed because the data retention period had ended. This study closed with the IRB in 2017 and further analysis cannot be conducted. As of the current year, 2024, all the raw data for this study no longer exists. The standard deviation cannot be calculated without the raw data.', 'groupId': 'OG000'}, {'value': '39.3', 'spread': 'NA', 'comment': 'The standard deviation was not calculated. Raw data existed during the study period of 2009 to 2013. This record was completed and published in 2016 without results. The data was subsequently destroyed because the data retention period had ended. This study closed with the IRB in 2017 and further analysis cannot be conducted. As of the current year, 2024, all the raw data for this study no longer exists. The standard deviation cannot be calculated without the raw data.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From glenoid implantation to completion of tendon or osteotomy repair', 'description': 'To be recorded in minutes, and documented by the surgical team', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only includes participants who completed the final follow-up.'}, {'type': 'SECONDARY', 'title': 'External Rotation (ER) Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenotomy', 'description': 'Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique.\n\nTSA with tenotomy technique: Standard procedure: Utilization of tenotomy for mobilization of subscapularis during total shoulder arthroplasty (TSA). The subscapularis tendon is incised close to its attachment on the humerus. The Tendon is repaired with sutures.\n\nShoulder prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.'}, {'id': 'OG001', 'title': 'Osteotomy', 'description': 'Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique.\n\nTSA with lesser tuberosity osteotomy technique: Standard procedure: Utilization of the osteotomy to mobilize the subscapularis during TSA. A small fleck of bone is removed from humerus, the subscapularis tendon is still attached. The fleck of bone is reattached with sutures.\n\nShoulder prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'spread': '2', 'groupId': 'OG000'}, {'value': '52', 'spread': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year post-operatively', 'description': 'Strength testing with Dynamometer in external rotation.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only includes participants who completed the final follow-up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tenotomy', 'description': 'Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique.\n\nTSA with tenotomy technique: Standard procedure: Utilization of tenotomy for mobilization of subscapularis during total shoulder arthroplasty (TSA). The subscapularis tendon is incised close to its attachment on the humerus. The Tendon is repaired with sutures.\n\nShoulder prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.'}, {'id': 'FG001', 'title': 'Osteotomy', 'description': 'Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique.\n\nTSA with lesser tuberosity osteotomy technique: Standard procedure: Utilization of the osteotomy to mobilize the subscapularis during TSA. A small fleck of bone is removed from humerus, the subscapularis tendon is still attached. The fleck of bone is reattached with sutures.\n\nShoulder prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tenotomy', 'description': 'Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique.\n\nTSA with tenotomy technique: Standard procedure: Utilization of tenotomy for mobilization of subscapularis during total shoulder arthroplasty (TSA). The subscapularis tendon is incised close to its attachment on the humerus. The Tendon is repaired with sutures.\n\nShoulder prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.'}, {'id': 'BG001', 'title': 'Osteotomy', 'description': 'Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique.\n\nTSA with lesser tuberosity osteotomy technique: Standard procedure: Utilization of the osteotomy to mobilize the subscapularis during TSA. A small fleck of bone is removed from humerus, the subscapularis tendon is still attached. The fleck of bone is reattached with sutures.\n\nShoulder prosthesis: Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '0-18 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'At least 18 years old', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Sex/gender were not collected from participants.'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-16', 'studyFirstSubmitDate': '2016-04-19', 'resultsFirstSubmitDate': '2021-08-12', 'studyFirstSubmitQcDate': '2016-05-03', 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-16', 'studyFirstPostDateStruct': {'date': '2016-05-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Radiologic Evidence of Anatomic Healing', 'timeFrame': 'Post operative at 1 year', 'description': 'Tendon healing/tuberosity union based on radiographs'}], 'secondaryOutcomes': [{'measure': 'Mean Visual Analogue Pain Scale (VAS)', 'timeFrame': '1 year post-operatively', 'description': 'Pain indication measurement where 0 indicates no pain and 10 indicates worst possible pain. Mean score is reported without a range or standard deviation.'}, {'measure': 'Forward Elevation (FE) Strength', 'timeFrame': '1 year post-operatively', 'description': 'Strength testing with Dynamometer in forward elevation was conducted to determine the mean in FE strength.'}, {'measure': 'Total Intra-Operative Time', 'timeFrame': 'From incision time to time of complete skin closure', 'description': 'To be recorded in minutes, and documented by the surgical team'}, {'measure': 'Total Subscapularis Repair Time (in Minutes)', 'timeFrame': 'From glenoid implantation to completion of tendon or osteotomy repair', 'description': 'To be recorded in minutes, and documented by the surgical team'}, {'measure': 'External Rotation (ER) Strength', 'timeFrame': '1 year post-operatively', 'description': 'Strength testing with Dynamometer in external rotation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Shoulder arthroplasty', 'Lesser Tuberosity Osteotomy', 'Subscapularis tenotomy'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '30771825', 'type': 'RESULT', 'citation': 'Levine WN, Munoz J, Hsu S, Byram IR, Bigliani LU, Ahmad CS, Kongmalai P, Shillingford JN. Subscapularis tenotomy versus lesser tuberosity osteotomy during total shoulder arthroplasty for primary osteoarthritis: a prospective, randomized controlled trial. J Shoulder Elbow Surg. 2019 Mar;28(3):407-414. doi: 10.1016/j.jse.2018.11.057.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the clinical effectiveness of two different techniques used for subscapularis tendon repair during total shoulder replacement. The investigators hypothesize that participants who receive a newer repair technique called a lesser tuberosity osteotomy will have lower rates of postoperative subscapularis muscle dysfunction and rupture as compared to those who receive the traditional tenotomy repair.', 'detailedDescription': 'The subscapularis tendon is mobilized during total shoulder arthroplasty in order to gain anterior access to the glenohumeral joint. Postoperative subscapularis dysfunction is being recognized more frequently and has been reported in \\>65% of patients following shoulder arthroplasty with a soft-tissue repair. Subscapularis dysfunction has been associated with poor functional outcomes including tendon rupture and anterior instability, a major indication for revision surgery. Recent studies suggest that a standard subscapularis tenotomy with primary tendon repair may lead to failure of the repair and decreased functional outcomes as compared to a more novel lesser tuberosity osteotomy technique. The investigators study aims to validate the results of the current literature in a prospective randomized controlled trial, which to their knowledge has not been reported on this topic.Investigators will compare clinical outcomes following these two techniques during total shoulder arthroplasty. Participants undergoing total shoulder replacement will be randomized to receive either a lesser tuberosity osteotomy or tenotomy with primary subscapularis tendon repair. All other procedures conducted in this study are considered standard of care except for ultrasounds, which are conducted for research purposes in the subscapularis tenotomy group. Postoperative outcomes will be monitored objectively and subjectively at routine postoperative office visits using physical exam, imaging (X-rays and ultrasounds), and questionnaires. If the hypothesis is proven to be true, the investigators will establish gold-standard evidence for the use of the newer osteotomy technique to improve patient satisfaction and mobility following shoulder arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients already scheduled for total shoulder arthroplasty\n\nExclusion Criteria:\n\n* Unable to provide information throughout postoperative recovery and attend subsequent office visits thereafter (a minimum of one year).'}, 'identificationModule': {'nctId': 'NCT02762903', 'briefTitle': 'Lesser Tuberosity Osteotomy for Subscapularis Repair', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Lesser Tuberosity Osteotomy Versus Tenotomy for Subscapularis Repair During Total Shoulder Arthroplasty', 'orgStudyIdInfo': {'id': 'AAAE1446'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tenotomy', 'description': 'Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique.', 'interventionNames': ['Procedure: TSA with tenotomy technique', 'Device: Shoulder prosthesis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Osteotomy', 'description': 'Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique.', 'interventionNames': ['Procedure: TSA with lesser tuberosity osteotomy technique', 'Device: Shoulder prosthesis']}], 'interventions': [{'name': 'TSA with tenotomy technique', 'type': 'PROCEDURE', 'description': 'Standard procedure: Utilization of tenotomy for mobilization of subscapularis during total shoulder arthroplasty (TSA). The subscapularis tendon is incised close to its attachment on the humerus. The Tendon is repaired with sutures.', 'armGroupLabels': ['Tenotomy']}, {'name': 'TSA with lesser tuberosity osteotomy technique', 'type': 'PROCEDURE', 'description': 'Standard procedure: Utilization of the osteotomy to mobilize the subscapularis during TSA. A small fleck of bone is removed from humerus, the subscapularis tendon is still attached. The fleck of bone is reattached with sutures.', 'armGroupLabels': ['Osteotomy']}, {'name': 'Shoulder prosthesis', 'type': 'DEVICE', 'description': 'Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.', 'armGroupLabels': ['Osteotomy', 'Tenotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'William N. Levine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}