Casting vs Bracing for Idiopathic Early-Onset Scoliosis

Study Purpose

Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	12 Months - 36 Months
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04500041
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Iowa
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Stuart L Weinstein, MD
Principal Investigator Affiliation	University of Iowa
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Canada, Hong Kong, Italy, New Zealand, Singapore, Turkey, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Scoliosis Idiopathic, Early-Onset Scoliosis Deformity of Spine

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Casting

Subjects will be treated with serial casting

Active Comparator: Bracing

Subjects will be treated with full-time orthotics (braces)

Interventions

Procedure: - Casting

Use of casts applied using corrective maneuvers

Device: - Bracing

Use of full-time spinal orthosis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Arkansas Children's Hospital, Little Rock, Arkansas

Status

Recruiting

Address

Arkansas Children's Hospital

Little Rock, Arkansas, 72202

Site Contact

Jennifer Ford

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