Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-02 @ 6:48 AM
Study NCT ID:
NCT03194568
Status:
COMPLETED
Last Update Posted:
2024-09-23
First Post:
2017-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vertebral Body Tethering Outcomes for Pediatric Idiopathic Scoliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cahillp1@chop.edu', 'phone': '2155901000', 'title': 'Dr. Patrick Cahill', 'organization': "Children's Hospital of Philadelphia"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected up to 2 years after the date of surgical implant for each subject. Additionally, the majority of the subjects enrolled in this study have also enrolled in an observational long-term follow up study.', 'description': 'Surgery and Post-operative Phase (Day 0 - POD 90): All AEs \\& SAEs will be noted.\n\nExtended Follow-up (POD 91-POD 730): All SAEs recorded. Only AEs which are deemed "device related" recorded.\n\nLong-term Follow-Up (POD 730 through two years after skeletal maturity): All SAEs identified from the medical records that are considered device related, up to two years after skeletal maturity, will be reported in accordance with FDA requirements. This will be performed under a separate research protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Anterior Vertebral Tethering', 'description': 'Subjects receiving Anterior Vertebral Tethering intervention.\n\nAnterior Vertebral Tether: Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Grade I', 'notes': 'Deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.\n\nAlso includes wound infections opened at the bedside.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 56, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Clavien-Dindo'}, {'term': 'Grade II', 'notes': 'Requiring pharmacological treatment with drugs other than such allowed for grade I complications.\n\nBlood transfusions and total parenteral nutrition are also included.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Clavien-Dindo'}, {'term': 'Grade I', 'notes': 'Deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.\n\nAlso includes wound infections opened at the bedside.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Clavien-Dindo'}, {'term': 'Grade I', 'notes': 'Deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.\n\nAlso includes wound infections opened at the bedside.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Clavien-Dindo'}, {'term': 'Grade I', 'notes': 'Deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.\n\nAlso includes wound infections opened at the bedside.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 52, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Clavien-Dindo'}, {'term': 'Grade I', 'notes': 'Deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.\n\nAlso includes wound infections opened at the bedside.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Clavien-Dindo'}, {'term': 'Grade I', 'notes': 'Deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.\n\nAlso includes wound infections opened at the bedside.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Clavien-Dindo'}, {'term': 'Grade I', 'notes': 'Deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.\n\nAlso includes wound infections opened at the bedside.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Clavien-Dindo'}, {'term': 'Grade I', 'notes': 'Deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.\n\nAlso includes wound infections opened at the bedside.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Clavien-Dindo'}], 'seriousEvents': [{'term': 'Grade IIIB', 'notes': 'Requiring surgical, endoscopic or radiological intervention under general anesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Clavien-Dindo'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anterior Vertebral Tethering', 'description': 'Subjects receiving Anterior Vertebral Tethering intervention.\n\nAnterior Vertebral Tether: Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.'}], 'classes': [{'title': 'Subjects that experienced a device-related AE', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Subjects that experienced a device-related SAE', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Subjects that experienced a non-device related AE', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Subjects that experienced a non-device related SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 2 years', 'description': 'Intra-operative and post-intervention medical events or signs and symptoms of complications arising after the start of study intervention will be captured. The event description, date of onset, end date, severity, and outcome will be documented. The frequencies, type, body system, severity, and relationship to the study intervention will also be summarized. A distinction will be made between those events which are "device-related" and "non device-related".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Four of the subjects were withdrawn from the study prior to the 2 year completion date due to need for re-operation related to an anticipated device SAE. All data reported for these subjects were obtained prior to withdrawal.'}, {'type': 'SECONDARY', 'title': 'Comparison of Pre-Operative and Post-Operative Cobb Angle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anterior Vertebral Tethering', 'description': 'Subjects receiving Anterior Vertebral Tethering intervention.\n\nAnterior Vertebral Tether: Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.'}], 'classes': [{'categories': [{'title': 'Thoracic curve <50° without a secondary spinal fusion or other revision surgery', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Thoracic curve >50°, or requiring a secondary spinal fusion or other revision surgery', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 2 years', 'description': 'The exploratory therapeutic endpoint used for feasibility will be change in post-operative Cobb angle compared to pre-operative Cobb angle, measured on coronal radiograph of the spine.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Four of the subjects were withdrawn from the study prior to the 2 year completion date due to need for re-operation related to an anticipated device SAE. All data reported for these subjects were obtained prior to withdrawal.'}, {'type': 'SECONDARY', 'title': 'Comparison of Pre-Operative and Post-Operative SRS 30 Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anterior Vertebral Tethering', 'description': 'Subjects receiving Anterior Vertebral Tethering intervention.\n\nAnterior Vertebral Tether: Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.'}], 'classes': [{'title': 'Pre-operative Function/Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Pre-operative Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Pre-operative Self-image/Appearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Pre-operative Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Pre-operative Satisfaction with management', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Pre-operative total score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Post-operative Function/Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Post-operative Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Post-operative Self-image/Appearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Post-operative Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Post-operative Satisfaction with management', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Post-operative total score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 years', 'description': 'The Scoliosis Research Society 30 (SRS-30) questionnaire will be administered at pre-operative and post-operative time points. This questionnaire measures health-related quality of life outcomes. It consists of 30 questions divided into five domains: Function/Activity (5 questions), Pain (5 questions), Self-image/Appearance (5 questions), Mental Health (5 questions), and Satisfaction with management (2 questions). The remaining 8 questions are a combination of different domains. Each question is scored on a 5-point scale (1 = worst, 5 = best). To score each domain, sum the scores of the questions within that domain and then divide by the number of questions in that domain to get an average score. To calculate the total overall score, sum all the individual question scores and then divide by the total number of questions (30). Higher scores indicate better health-related quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Four of the 20 initial subjects were withdrawn from the study prior to final follow-up administration of SRS questionnaire.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Anterior Vertebral Tethering', 'description': 'Subjects receiving Anterior Vertebral Tethering intervention.\n\nAnterior Vertebral Tether: Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawn due to need for re-operation related to an anticipated device SAE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Anterior Vertebral Tethering', 'description': 'Subjects receiving Anterior Vertebral Tethering intervention.\n\nAnterior Vertebral Tether: Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12', 'spread': '1.94', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age at first diagnosis of Idiopathic Scoliosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9', 'spread': '2.38', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Menarche status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'N/A, Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height (cm)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '159.4', 'spread': '12.43', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight (kg)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '45.8', 'spread': '13.82', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Degree of thoracic rib hump', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'spread': '4.64', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'description': 'Data collected using a scoliometer', 'unitOfMeasure': 'Degrees', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Thoracic Rib Hump Side', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Right', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Left', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Degree of lumbar rib hump', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6', 'spread': '2.72', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'description': 'Data collected using a scoliometer', 'unitOfMeasure': 'Degrees', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Lumbar rib hump side', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Left', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Right', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Coronal Thoracic Cobb Angle', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '51.5', 'spread': '7.25', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Degrees', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Coronal Lumbar Cobb Angle', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29', 'spread': '6.77', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Degrees', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Bending Thoracic Cobb Angle', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '20.5', 'spread': '10.56', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Degrees', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Bending Lumbar Cobb Angle', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'spread': '9.83', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Degrees', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Lumbar bending X-Ray not taken for 1 subject at baseline'}, {'title': 'Sanders Bone Age', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '2', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '3', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '4', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '5', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '6', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '7', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '8', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Based on a scale of 0-8, the Sanders maturity scale considers level 0 to be slow growth in early adolescence whereas 8 is categorized as full skeletal maturity', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-27', 'size': 933681, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-07T09:04', 'hasProtocol': True}, {'date': '2020-03-02', 'size': 306339, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-04-07T09:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-16', 'studyFirstSubmitDate': '2017-06-12', 'resultsFirstSubmitDate': '2023-04-12', 'studyFirstSubmitQcDate': '2017-06-19', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-16', 'studyFirstPostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'up to 2 years', 'description': 'Intra-operative and post-intervention medical events or signs and symptoms of complications arising after the start of study intervention will be captured. The event description, date of onset, end date, severity, and outcome will be documented. The frequencies, type, body system, severity, and relationship to the study intervention will also be summarized. A distinction will be made between those events which are "device-related" and "non device-related".'}], 'secondaryOutcomes': [{'measure': 'Comparison of Pre-Operative and Post-Operative Cobb Angle', 'timeFrame': 'up to 2 years', 'description': 'The exploratory therapeutic endpoint used for feasibility will be change in post-operative Cobb angle compared to pre-operative Cobb angle, measured on coronal radiograph of the spine.'}, {'measure': 'Comparison of Pre-Operative and Post-Operative SRS 30 Scores', 'timeFrame': 'up to 2 years', 'description': 'The Scoliosis Research Society 30 (SRS-30) questionnaire will be administered at pre-operative and post-operative time points. This questionnaire measures health-related quality of life outcomes. It consists of 30 questions divided into five domains: Function/Activity (5 questions), Pain (5 questions), Self-image/Appearance (5 questions), Mental Health (5 questions), and Satisfaction with management (2 questions). The remaining 8 questions are a combination of different domains. Each question is scored on a 5-point scale (1 = worst, 5 = best). To score each domain, sum the scores of the questions within that domain and then divide by the number of questions in that domain to get an average score. To calculate the total overall score, sum all the individual question scores and then divide by the total number of questions (30). Higher scores indicate better health-related quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Scoliosis', 'Idiopathic Scoliosis', 'Adolescent Idiopathic Scoliosis'], 'conditions': ['Idiopathic Scoliosis']}, 'descriptionModule': {'briefSummary': 'This study will assess whether Anterior Vertebral Tethering is a safe and feasible method of anterior approach surgery for spinal deformity in pediatric idiopathic scoliosis.', 'detailedDescription': 'Scoliosis is a condition in which the spine is deformed by a curvature in the coronal plane. It is generally associated with a twisting (axial plane) deformity as well. It can have a variety of underlying etiologies and the etiology is used to classify the types of scoliosis. Idiopathic scoliosis is sub-classified in two ways: by age of onset and by magnitude of deformity. Curves between 10 and 25 degrees are considered mild. Curves between 25 and 50 degrees are classified as moderate. Curves greater than 50 degrees are termed severe. The current standard of care for moderate scoliosis in patients with remaining growth is to utilize a thoracolumbosacral orthosis (TLSO brace) to prevent progression of deformity. The scientific evidence has supported the efficacy of this intervention in avoiding progression of the Cobb angle to 50 degrees or more.\n\nIf treated with a TLSO brace, many idiopathic scoliosis patients would conceivably be subjected to years of brace wear and the cost and psychological factors inherent therein. Additional downsides of brace treatment include the potentially negative psychosocial impact of wearing an external sign of deformity during adolescence, a key period of emotional development. Prior research has identified negative psychosocial effects related to wearing a brace in children.\n\nRecent evidence has suggested that certain curve patterns will likely progress to 50 degrees or more, despite treatment with a TLSO brace. Sanders, et al. demonstrated a correlation of Cobb angle (greater than 35 degrees) and skeletal maturity (bone age 4 or less) to the risk of progression to 50 degrees or more, despite TLSO bracing. The evidence supports that the current practice of TLSO bracing is not an effective treatment to avoid progression to 50 degrees in these patients. It is on this population (thoracic Cobb angle greater than 35 degrees, bone age of 4 or less) that we intend to test the safety and feasibility of Anterior Vertebral Body Tethering to avoid curve progression to 50 degrees.\n\nThe study intervention is surgical orthopedic implantation of the Anterior Vertebral Tether Device, by way of thoracoscopic surgery under general anesthesia. The primary outcome measures include assessments of safety of the insertion procedure and of the device, as well as the secondary measure of feasibility by determining the ability to successfully implant the investigational device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males or females age 8 to 16 years old at time of enrollment (inclusive)\n2. Diagnosis of idiopathic scoliosis\n3. Sanders bone age of less than or equal to 4\n4. Thoracic curve of greater than or equal to 35 degrees and less than or equal to 60 degrees\n5. Lumbar curve less than 35 degrees\n6. Patient has already been identified for and recommended to have surgical intervention\n7. Spina bifida occulta is permitted\n8. Spondylolysis or Spondylolisthesis is permitted, as long as it is non-operative, the subject has not had any previous surgery for this, and no surgery is planned in the future\n\nExclusion Criteria:\n\n1. Pregnancy (current)\n2. Prior spinal or chest surgery\n3. MRI abnormalities (including syrinx greater than 4mm, Chiari malformation, or tethered cord)\n4. Neuromuscular, thoracogenic, cardiogenic scoliosis, or any other non-idiopathic scoliosis\n5. Associated syndrome, including Marfan syndrome or neurofibromatosis\n6. Sanders bone age greater than 4\n7. Thoracic curve less than 35 degrees or greater than 60 degrees\n8. Lumbar curve greater than or equal to 35 degrees\n9. Unable or unwilling to firmly commit to returning for required follow-up visits\n10. Investigator judgement that the subject/family may not be a candidate for the intervention'}, 'identificationModule': {'nctId': 'NCT03194568', 'briefTitle': 'Vertebral Body Tethering Outcomes for Pediatric Idiopathic Scoliosis', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Safety and Feasibility of a Vertebral Body Tethering Technique for Pediatric Idiopathic Scoliosis', 'orgStudyIdInfo': {'id': '17-013694'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anterior Vertebral Tethering', 'description': 'Subjects receiving Anterior Vertebral Tethering intervention.', 'interventionNames': ['Device: Anterior Vertebral Tether']}], 'interventions': [{'name': 'Anterior Vertebral Tether', 'type': 'DEVICE', 'description': 'Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.', 'armGroupLabels': ['Anterior Vertebral Tethering']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "The Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Patrick Cahill, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Patrick Cahill, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Attending Orthopaedic Surgeon', 'investigatorFullName': 'Patrick Cahill, MD', 'investigatorAffiliation': "Children's Hospital of Philadelphia"}}}}