[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503097":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":15,"centralContacts":20,"locations":26,"responsibleParty":71,"collaborators":7,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":7,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":7,"studyType":86,"phases":7,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":29,"whyStopped":7,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},{"fullName":5,"class":6},"Highridge Medical","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"PROCEDURE","Vertebral Body Tethering (VBT)","Vertebral Body Tethering surgery with the Tether™ in UK",[14],"The Tether™ - VBT System",[16],{"name":17,"affiliation":18,"role":19},"Jason Bernard, MD","Saint George's Hospital, London","PRINCIPAL_INVESTIGATOR",[21],{"name":22,"role":23,"phone":24,"phoneExt":7,"email":25},"Delphine Lebrasseur-Longuet","CONTACT","+33 626262240","ClinicalEMEA@highridgemedical.com",[27,45,58],{"facility":28,"status":29,"city":30,"state":7,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Saint George's Hospital","RECRUITING","London","SW17 0QT","United Kingdom","UK",{"type":35,"coordinates":36},"Point",[37,38],-0.12574,51.50853,{"lat":38,"lon":37},[41,44],{"name":42,"role":23,"phone":7,"phoneExt":7,"email":43},"Jason BERNARD, MD","jason.bernard@stgeorges.nhs.uk",{"name":42,"role":19,"phone":7,"phoneExt":7,"email":7},{"facility":46,"status":29,"city":47,"state":7,"zip":7,"country":32,"countryCode":33,"cosmosGeoPoint":48,"geoPoint":52,"contacts":53},"Freeman Hospital","Newcastle upon Tyne",{"type":35,"coordinates":49},[50,51],-1.61396,54.97328,{"lat":51,"lon":50},[54,57],{"name":55,"role":23,"phone":7,"phoneExt":7,"email":56},"Andrew BOWEY, MD","andrew.bowey@nhs.net",{"name":55,"role":19,"phone":7,"phoneExt":7,"email":7},{"facility":59,"status":29,"city":60,"state":7,"zip":7,"country":32,"countryCode":33,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"University Southampton Hospital","Southampton",{"type":35,"coordinates":62},[63,64],-1.40428,50.90395,{"lat":64,"lon":63},[67,70],{"name":68,"role":23,"phone":7,"phoneExt":7,"email":69},"Andrew COTTAM, MD","acottam@nhs.net",{"name":68,"role":19,"phone":7,"phoneExt":7,"email":7},{"type":72,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100503097","pmcf-post-market-clinical-follow-up-study-on-the-tether-in-uk-united-kingdom-100503097",false,"NCT05830825","PMCF (Post-Market Clinical Follow-up) Study on The Tether™ in UK (United Kingdom)","The Tether™ - Vertebral Body Tethering System Post-Market Clinical Follow-Up Study in UK","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 bracing and\u002For be intolerant to brace wear;\n* Lenke Type 1 curves (i.e., main thoracic);\n* Signed Informed Consent Form by legal guardian or by the patient if ≥ 16 years old.\n* The decision to treat patients with The Tether™ - VBT System was made by the patient's clinician outside of this research\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* Known poor bone quality defined as a T-score -1.5 or less;\n* Skeletal maturity;\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 patients 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* Patients who are pregnant at the time of enrollment.","ALL","0 Years","30 Years",{"count":84,"type":85},100,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to collect information about The Tether™ device in participants with progressive idiopathic scoliosis, Lenke Type 1 curves. The main purpose is to provide assessment of:\n\n* ongoing safety\n* probable benefits Participants who will receive The Tether™ during spine surgery will have to attend follow-up visits which are part of standard-of-care.",[89],"Scoliosis Idiopathic",[91,92],"Vertebral Body Tethering","Fusionless Spine Surgery","2025-03-20",{"date":95,"type":96},"2025-03-21","ACTUAL",{"date":98,"type":96},"2024-07-18",{"date":100,"type":85},"2033-12",{"name":102,"class":6},"LDR Médical SAS",3]