[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100401310":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":22,"locations":31,"responsibleParty":167,"collaborators":169,"id":176,"slug":177,"hasResults":178,"nctId":179,"briefTitle":180,"officialTitle":180,"acronym":10,"eligibilityCriteria":181,"healthyVolunteers":178,"sex":182,"minAge":10,"maxAge":10,"enrollmentInfo":183,"targetDuration":186,"studyType":187,"phases":10,"briefSummary":188,"conditions":189,"keywords":10,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},{"fullName":5,"class":6},"ZimVie","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Tether",null,"Patients who have received The Tether HUD for treatment of idiopathic scoliosis.",[13],"Device: Anterior Vertebral Body Tethering",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Anterior Vertebral Body Tethering","Anterior Vertebral Body Tethering (AVBT) is a technique that utilizes growth modulation to remodel the shape of the vertebra and straighten scoliotic curves in skeletally immature individuals. In this technique, screws are inserted at each vertebral level for the length of the convex side of the curve. A strong cord is connected through the screw tulip heads and used to initially straighten the curve as each level is fixed with a set screw. Following surgery and during the growth period the spine begins to remodel according to the Hueter-Volkmann Law, bone growth is relatively inhibited in areas of increased pressure (convex or tethered side) and relatively stimulated in areas of decreased pressure or tension (concave side).",[9],[21],"AVBT",[23,28],{"name":24,"role":25,"phone":26,"phoneExt":10,"email":27},"Monica Barascout, BS","CONTACT","1-303-465-8960","Monica.Barascout@zimvie.com",{"name":29,"role":25,"phone":26,"phoneExt":10,"email":30},"Kim Martinez","Kim.Martinez@zimvie.com",[32,50,63,74,87,100,115,129,141,154],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Rady Children's Hospital","RECRUITING","San Diego","California","92123","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-117.16472,32.71571,{"lat":44,"lon":43},[47],{"name":48,"role":25,"phone":49,"phoneExt":10,"email":10},"Peter O Newton, MD","858-966-6789",{"facility":51,"status":34,"city":52,"state":53,"zip":54,"country":38,"countryCode":39,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Children's Hospital Colorado","Aurora","Colorado","80045",{"type":41,"coordinates":56},[57,58],-104.83192,39.72943,{"lat":58,"lon":57},[61],{"name":62,"role":25,"phone":10,"phoneExt":10,"email":10},"Mark Erickson, MD",{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":38,"countryCode":39,"cosmosGeoPoint":69,"geoPoint":73,"contacts":10},"Nemours Children's Health","ACTIVE_NOT_RECRUITING","Jacksonville","Florida","32207",{"type":41,"coordinates":70},[71,72],-81.65565,30.33218,{"lat":72,"lon":71},{"facility":75,"status":34,"city":76,"state":77,"zip":78,"country":38,"countryCode":39,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Children's Healthcare of Atlanta","Atlanta","Georgia","30342",{"type":41,"coordinates":80},[81,82],-84.38798,33.749,{"lat":82,"lon":81},[85],{"name":86,"role":25,"phone":10,"phoneExt":10,"email":10},"Joshua Murphy, MD",{"facility":88,"status":34,"city":89,"state":90,"zip":91,"country":38,"countryCode":39,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Ochsner Health","New Orleans","Louisiana","70121",{"type":41,"coordinates":93},[94,95],-90.07507,29.95465,{"lat":95,"lon":94},[98],{"name":99,"role":25,"phone":10,"phoneExt":10,"email":10},"Lawrence Haber, MD",{"facility":101,"status":34,"city":102,"state":103,"zip":104,"country":38,"countryCode":39,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Mayo Clinic","Rochester","Minnesota","55905",{"type":41,"coordinates":106},[107,108],-92.4699,44.02163,{"lat":108,"lon":107},[111],{"name":112,"role":25,"phone":113,"phoneExt":10,"email":114},"A. Noelle Larson, MD","507-284-3660","Larson.noelle@mayo.edu",{"facility":116,"status":34,"city":117,"state":118,"zip":119,"country":38,"countryCode":39,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"University of Missouri - Columbia","Columbia","Missouri","65201",{"type":41,"coordinates":121},[122,123],-92.33407,38.95171,{"lat":123,"lon":122},[126],{"name":127,"role":25,"phone":128,"phoneExt":10,"email":10},"Daniel Hoernschemeyer, MD","573-882-2663",{"facility":130,"status":34,"city":131,"state":131,"zip":132,"country":38,"countryCode":39,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Mount Sinai","New York","10029",{"type":41,"coordinates":134},[135,136],-74.00597,40.71427,{"lat":136,"lon":135},[139],{"name":140,"role":25,"phone":10,"phoneExt":10,"email":10},"Baron Lonner, MD",{"facility":142,"status":34,"city":143,"state":144,"zip":145,"country":38,"countryCode":39,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Shriners Children's Hopital","Philadelphia","Pennsylvania","19140",{"type":41,"coordinates":147},[148,149],-75.16362,39.95238,{"lat":149,"lon":148},[152],{"name":153,"role":25,"phone":10,"phoneExt":10,"email":10},"Amer F Samdani",{"facility":155,"status":34,"city":156,"state":157,"zip":158,"country":38,"countryCode":39,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Seattle Children's","Seattle","Washington","98105",{"type":41,"coordinates":160},[161,162],-122.33207,47.60621,{"lat":162,"lon":161},[165],{"name":166,"role":25,"phone":10,"phoneExt":10,"email":10},"Burt Yaszay, MD",{"type":168,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[170,173],{"name":171,"class":172},"Setting Scoliosis Straight Foundation","OTHER",{"name":174,"class":175},"Exponent, Inc.","UNKNOWN","100401310","the-tether---vertebral-body-tethering-system-post-approval-study-100401310",false,"NCT04505579","The Tether™ - Vertebral Body Tethering System Post Approval Study","Inclusion Criteria:\n\n* Diagnosis of progressive idiopathic scoliosis\n* Skeletally immature, based on both Risser (\\\u003C5) and Sanders (\\\u003C8) assessments\n* Major Cobb angle ≥30° and ≤65°\n* Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging\n* Failed or intolerant to bracing\n\nExclusion Criteria:\n\n* Presence of any systemic infection, local infection, or skin compromise at the surgical site\n* Prior spinal surgery at the level(s) to be treated\n* Documented poor bone quality, defined as a T-score -1.5 or less\n* Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions\n* Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent\n* Unwillingness to sign Informed Consent Form and participate in study procedures","ALL",{"count":184,"type":185},200,"ESTIMATED","5 Years","OBSERVATIONAL","This study is an opportunity to provide continued reasonable assurance of the safety and probable benefit of The Tether HUD. The study will collect long term safety and efficacy information from patients who have had their idiopathic scoliosis treated via anterior vertebral body tethering (AVBT) with The Tether.",[190],"Scoliosis Idiopathic","2024-02-21",{"date":193,"type":194},"2024-02-22","ACTUAL",{"date":196,"type":194},"2020-10-29",{"date":198,"type":185},"2027-12-31",{"name":5,"class":6},10]