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Активно (без набиране) Не е приложимо NCT04500041

Casting vs Bracing for Idiopathic Early-Onset Scoliosis

Не е приложима фаза (напр. обсервационно)
Заболявания: Scoliosis Idiopathic Early-Onset Scoliosis Deformity of Spine

Спонсор: University of Iowa

Налично на: БГ
Обобщение
Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis
Описание
This study uses a multicenter, prospective hybrid research design, which will combine two methods of treatment assignment (randomized and parent preference) and an embedded internal pilot study for sample size re-estimation. Patients will be treated either with serial casts or a full-time brace and followed until curve resolution, failure or palliation (neither resolution nor failure after 2 years of treatment). Results of this study will provide clinicians and families with evidence to support informed treatment decisions.
Кой може да участва
Will enroll both patients with scoliosis and 1 of their parents/guardians Inclusion Criteria: Patient Inclusion * Diagnosis of idiopathic early-onset scoliosis * Child standing independently but not older than 3 years of age * 20≤ Cobb angle ≤70° (largest structural curvature) * Rib-vertebral angle difference (RVAD) greater than 20 degrees or Rib Phase II * Parental consent to participate Parent Inclusion * Parent or guardian of the minor subject * Consent to participate * Able to complete surveys Exclusion Criteria: Patient Exclusion * Previous operative or non-operative treatment for idiopathic early-onset scoliosis * Not independently walking by 18 months of age or other signs/symptoms indicative of developmental delay
Места на провеждане 3
Италия (1)
Italian Scientific Spine Institute (ISICO)
Milan
New Zealand (1)
Starship Child Health
Auckland
САЩ (1)
Arkansas Children's Hospital
Little Rock , Arkansas
Технически детайли
Статус
Активно (без набиране)
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
12 Months
Максимална възраст
36 Months
Здрави доброволци
Не
Начална дата
09.02.2021
Крайна дата
30.09.2026
Регистрационен номер
NCT04500041
Източник
anzctr
Запитване за медицински туризъм

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