Development of a Conservative Care and Bracing Registry (CCBR)

NCT07527611 | Completed

• 1 other identifier: 20242360
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

adolescent idiopathic scoliosis; early onset scoliosis; brace; treatment; curve correction

Outcome Measures

Primary Outcomes (2)

• Surgery

  proportion of subjects ending growth with curves exceeding 50 Cobb degrees and needing surgery compared to proportion of subjects ending around the healthy threshold (30 Cobb degrees) with those in between.

  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).

• Cobb angle

  The Cobb angle is the measure of the Curve magnitude. It is a continuous measure that changes over time. It will be considered as a continuous measure in panel data format or as a difference from baseline to the end of follow up. Clinically meaningful changes must exceed the measurment error which is 5 Cobb degrees.

  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).

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Scoliosis subjects treated with brace provided by a single orthotist clinic which provided highly specialised braces managed according to different protocols.

You may qualify if:

• All scoliosis type included

You may not qualify if:

• prior brace treatment or missing baseline information or missing information not allowing any comparisons.

Sponsors & Collaborators

• National Scoliosis Center: lead

Study Sites (1)

National scoliosis center

Fairfax, Virginia, 22031, United States

Location

Related Links

• Related Info

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: April 14, 2026
• Study Start: June 30, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)