Development of a Conservative Care and Bracing Registry (CCBR)

Part of paid clinical trials in Fairfax, Virginia.

Sponsor
National Scoliosis Center
Study ID
NCT07527611
Status
Completed

Conditions

  • Adolescent Idiopathic Scoliosis (AIS)
  • Ealy Onset Scoliosis
  • Infantile Idiopathic Scoliosis
  • Juvenile Idiopathic Scoliosis
  • Neuromuscular Scoliosis

Eligibility Criteria

Sex
ALL
Age
1 Year - 18 Years
Healthy Volunteers
Not accepted

Study Details

Idiopathic scoliosis (IS) is a common problem affecting approximately 3% of the population; its progression can lead to significant health problems. The BrAIST study proved brace effectiveness, which increased bracing interest and utilization globally. There is a lack of evidence-based guidelines for brace treatment. There is significant variability in the brace literature with little consistency in indications for brace treatment goals, brace types, use of monitors, timing of radiographs, and evaluation of skeletal maturity. This lack of evidence demonstrates a clear need for a multi-center brace registry. The first aim of this proposal is to develop a comprehensive retrospective brace registry. This project involves expert clinicians, researchers and an orthotist, each with broad clinical and research experience in the field of bracing for scoliosis. The retrospective registry will function as a pilot, providing strategies to optimize variables, streamline data collection and minimize missing data. The next step will be to develop and launch a multicenter, prospective brace registry and Quality Improvement registry.

Key Dates

Start date
Jun 30, 2024
Status verified
Apr 2026
Primary completion
Nov 1, 2025
Completion
Nov 1, 2025

Study Design

Enrollment
280 participants (actual)

Primary Outcome Measure

Surgery [ Time Frame: Minimum of 2 years from baseline, corresponding to the first brace delivery, through end of growth. End of growth is defined by bone maturity evaluation (Risser >3 Sanders>6). ]

Locations (1)

FacilityCityStateZIPSite coordinators
National scoliosis centerFairfaxVirginia22031-

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