[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576431":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":54,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":20,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":44,"whyStopped":20,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Baylor College of Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"3D-printed brace","EXPERIMENTAL","Enrolled participants will be fit with a 3D printed brace. The brace will be made using the exact same shape as their current brace. The fitting procedures will also remain the same.",[13],"Device: 3D-printed scoliosis brace",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","3D-printed scoliosis brace","Scoliosis brace will be 3D printed using a Filament Innovations Icarus printer and the material CPX. There will be corrugations where extra strength is needed. The brace will be made using the same shape as the participant's current brace to minimize variables at play.\n\nAccording to Sec. 890.3490 of the Code of Federal Regulations Title 21, scoliosis braces are Class I devices, requiring only general controls. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Megan EG Castille, MS","CONTACT","713-798-3098","megan.glahn@bcm.edu",[28,42],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":20},"University of Texas Health Science Center at Houston","COMPLETED","Houston","Texas","77030","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-95.36327,29.76328,{"lat":40,"lon":39},{"facility":43,"status":44,"city":45,"state":32,"zip":46,"country":34,"countryCode":35,"cosmosGeoPoint":47,"geoPoint":51,"contacts":52},"Align Clinic","RECRUITING","The Woodlands","77380",{"type":37,"coordinates":48},[49,50],-95.48938,30.15799,{"lat":50,"lon":49},[53],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Megan Elizabeth Castille","Assistant Professor",[59],{"name":60,"class":61},"Scoliosis Research Society (SRS)","UNKNOWN","100576431","rethinking-rigidity-development-of-a-3d-printed-scoliosis-brace-with-varying-flexibility-100576431",false,"NCT06785207","Rethinking Rigidity: Development of a 3D-Printed Scoliosis Brace With Varying Flexibility","3DSCOLIBRACE","Inclusion Criteria:\n\n1. Have a diagnosis of juvenile idiopathic scoliosis or adolescent idiopathic scoliosis\n2. Have a Cobb angle between 20-40 degrees\n3. Are between ages 8-18\n4. Present as Risser 2+ on x-ray\n5. Currently wear a traditionally fabricated scoliosis brace\n6. Have good brace adherence in current brace (self-reported to be 75% of prescribed time)\n7. Be an established patient of Align Clinic and Dr. Timothy Borden\n8. Speak English (survey and semi-structured interview will only be available in English)\n9. Assent and receive parental consent\n\nExclusion Criteria:\n\n1. Have a diagnosis other than juvenile idiopathic scoliosis or adolescent idiopathic scoliosis\n2. Have a Cobb angle outside the range of 20-40 degrees\n3. Present as Risser 0 or 1\n4. Do not currently wear a traditionally fabricated scoliosis brace\n5. Have poor adherence in their current brace\n6. Do not speak English\n7. Are not willing participate in the study","ALL","8 Years","18 Years",{"count":73,"type":74},5,"ESTIMATED","INTERVENTIONAL",[77],"NA","Scoliosis bracing is an effective treatment method for idiopathic scoliosis, but only if worn consistently for many hours a day. Unsurprisingly, brace discomfort is a significant deterrent against treatment adherence. For decades, custom braces for idiopathic scoliosis have been fabricated using one of three materials - copolymer, polypropylene, or polyethylene. The application of the biomechanical principles behind bracing have improved over the years, but the materials have not. The investigators' goal is to expand fabrication options by testing a 3D-printed scoliosis brace with variable flexibility. The aim is to improve patients' perceived brace comfort.\n\nAfter optimizing the brace design, the investigators will collect patient feedback about the design from currently braced participants. These participants understand what a standard brace feels like and will provide impactful feedback.",[80],"Scoliosis Idiopathic Adolescent Treatment",[17,82,83,84],"scoliosis brace","scoliosis bracing","3D-printing","2026-06-01",{"date":87,"type":88},"2026-06-02","ACTUAL",{"date":90,"type":88},"2025-04-01",{"date":92,"type":74},"2026-10-31",{"name":5,"class":6},2]