[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03506334":3,"trial-entities:NCT03506334":90,"trial-summary:NCT03506334":94},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":14,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":40,"secondary_outcomes":45,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":68,"locations":70,"central_contacts":79,"overall_officials":80,"references":84,"see_also_links":89},"NCT03506334","17-007801","Anterior Vertebral Body Tethering (AVBT) Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis","Prospective Pilot Study of Anterior Vertebral Body Tethering Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis","ENROLLING_BY_INVITATION","2027-05","2026-07","2026-07-07","2018-04-25","Mayo Clinic","OTHER",true,"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.",null,[19],"Scoliosis",[],"INTERVENTIONAL",[23],"NA",{"count":25,"type":26},80,"ESTIMATED",[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","AVBT using Dynesys System Components","Zimmer Biomet Tether System and Dynesys System components are intended to treat scoliosis in skeletally immature children.",[33],"Pediatric Scoliosis Patients",{"type":35,"name":36,"description":37,"armGroupLabels":38},"PROCEDURE","Spine fusion","Children with scoliosis undergoing fusion surgery will form the control arm",[39],"Pediatric Scoliosis Control Patients",[41],{"measure":42,"description":43,"timeFrame":44},"Revision spine surgery within 2 years of index procedure","yes\u002Fno parameter, was revision surgery performed within 2 years of index procedure","2 years",[46,50,53,57],{"measure":47,"description":48,"timeFrame":49},"Major cobb angle curve progression greater than 10 degrees and curve magnitude \u003C 50 degrees at latest f\u002Fu after 1st erect postop film (Tether arm)","yes\u002Fno parameter, did major Cobb angle worsen by 10 degrees and curve magnitude \\\u003C 50 degrees at latest f\u002Fu after 1st erect postop film","1 year",{"measure":51,"description":52,"timeFrame":49},"Curve progression no greater than 10 degrees at latest f\u002Fu after 1st erect postop film (Fusion arm)","yes\u002Fno parameter, did major Cobb angle worsen by 10 degrees at latest f\u002Fu after 1st erect postop film",{"measure":54,"description":55,"timeFrame":56},"Curve flexibility over instrumented vertebra > 5 degrees","Flexibility films will be obtained in patients postoperatively to assess flexibility","At least 1 year postoperatively",{"measure":58,"description":59,"timeFrame":56},"Spinal disc health utilizing MRI","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).","ALL","10 Years","16 Years",false,{"inclusion":65,"exclusion":66,"raw_text":67},[],[],"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.",[69],"CHILD",[71],{"facility":13,"city":72,"state":73,"zip":74,"country":75,"geoPoint":76},"Rochester","Minnesota","55905","United States",{"lat":77,"lon":78},44.02163,-92.4699,[],[81],{"name":82,"affiliation":13,"role":83},"A. Noelle Larson, MD","PRINCIPAL_INVESTIGATOR",[85],{"pmid":86,"type":87,"citation":88},"35610543","DERIVED","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\u002Fs43390-022-00519-3. Epub 2022 May 24.",[],{"nct_id":4,"conditions":91,"biomarkers":93},[92],"Adolescent idiopathic scoliosis",[],{"nct_id":4,"found":63,"summary":17,"prompt_version":17}]