Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-01-08 @ 11:39 AM
Study NCT ID:
NCT03506334
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-11
First Post:
2018-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anterior Vertebral Body Tethering (AVBT) Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Tether group 40 patients and Fusion (control) group 40 patients'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-09', 'studyFirstSubmitDate': '2018-04-03', 'studyFirstSubmitQcDate': '2018-04-16', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Revision spine surgery within 2 years of index procedure', 'timeFrame': '2 years', 'description': 'yes/no parameter, was revision surgery performed within 2 years of index procedure'}], 'secondaryOutcomes': [{'measure': 'Major cobb angle curve progression greater than 10 degrees and curve magnitude < 50 degrees at latest f/u after 1st erect postop film (Tether arm)', 'timeFrame': '1 year', 'description': 'yes/no parameter, did major Cobb angle worsen by 10 degrees and curve magnitude \\< 50 degrees at latest f/u after 1st erect postop film'}, {'measure': 'Curve progression no greater than 10 degrees at latest f/u after 1st erect postop film (Fusion arm)', 'timeFrame': '1 year', 'description': 'yes/no parameter, did major Cobb angle worsen by 10 degrees at latest f/u after 1st erect postop film'}, {'measure': 'Curve flexibility over instrumented vertebra > 5 degrees', 'timeFrame': 'At least 1 year postoperatively', 'description': 'Flexibility films will be obtained in patients postoperatively to assess flexibility'}, {'measure': 'Spinal disc health utilizing MRI', 'timeFrame': 'At least 1 year postoperatively', 'description': 'Spinal disc health will be assessed in Tether patients post-operatively using an MRI in conjunction with the Pfirrmann classification (scored I to V, where I indicated normal and V indicated the worst degeneration).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Scoliosis']}, 'referencesModule': {'references': [{'pmid': '35610543', 'type': 'DERIVED', 'citation': 'Mathew SE, Hargiss JB, Milbrandt TA, Stans AA, Shaughnessy WJ, Larson AN. Vertebral body tethering compared to posterior spinal fusion for skeletally immature adolescent idiopathic scoliosis patients: preliminary results from a matched case-control study. Spine Deform. 2022 Sep;10(5):1123-1131. doi: 10.1007/s43390-022-00519-3. Epub 2022 May 24.'}]}, 'descriptionModule': {'briefSummary': 'The Researchers want to assess the short-term safety of Anterior Vertebral Body Tethering (AVBT) in skeletally immature subjects with moderate to severe scoliosis and compare them with a fusion cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male \\& female, age 10 years to 16 years.\n2. Scoliosis curve between 40-70 degrees.\n3. At least 1 year of growth remaining measured by Sanders bone age 4 or less or Risser stage 2 or less.\n4. Adolescent idiopathic scoliosis.\n5. Lenke 1, 2, 3C, 5 (thoracic, thoracolumbar, or thoracic and lumbar).\n6. Parents must be able to understand the study and sign the consent document. Assent will be obtained and documented as age appropriate.\n7. Patients and parents must be able to comply with study procedures and visits, including 3-month, 1-year, and 2-year follow-up visits.\n\nExclusion Criteria:\n\n1. Congenital, neuromuscular or syndromic scoliosis.\n2. Underlying neuromuscular disease.\n3. Pregnancy.\n4. Nonflexible curves (bending films show residual curve greater than 40 degrees).\n5. Prior surgery for scoliosis treatment.\n6. Patients with active systemic infection.\n7. Known, reported allergies to titanium, PET, or PCU. Known, reported substance abuse, including alcohol.'}, 'identificationModule': {'nctId': 'NCT03506334', 'briefTitle': 'Anterior Vertebral Body Tethering (AVBT) Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Prospective Pilot Study of Anterior Vertebral Body Tethering Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis', 'orgStudyIdInfo': {'id': '17-007801'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pediatric Scoliosis Patients', 'description': 'Tether group', 'interventionNames': ['Device: AVBT using Dynesys System Components']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pediatric Scoliosis Control Patients', 'description': 'Fusion (control) group', 'interventionNames': ['Procedure: Spine fusion']}], 'interventions': [{'name': 'AVBT using Dynesys System Components', 'type': 'DEVICE', 'description': 'Zimmer Biomet Tether System and Dynesys System components are intended to treat scoliosis in skeletally immature children.', 'armGroupLabels': ['Pediatric Scoliosis Patients']}, {'name': 'Spine fusion', 'type': 'PROCEDURE', 'description': 'Children with scoliosis undergoing fusion surgery will form the control arm', 'armGroupLabels': ['Pediatric Scoliosis Control Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'A. Noelle Larson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'A. Noelle Larson, MD', 'investigatorAffiliation': 'Mayo Clinic'}}}}