A New Spinal Brace Design Concept for the Treatment of Adolescent Idiopathic Scoliosis

NCT03365804 | Terminated

• 1 other identifier: Pro00054113
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the spine due to an unknown cause. Bracing is a proven non-surgical treatment for scoliosis. Our group developed an ultrasound assisted method which can improve brace design. However, it is still quite time consuming to construct a brace. Although 3D printing technology has been proposed to construct a scoliosis brace, its effectiveness has not been validated. The goals of this study was to investigate if an effective and comfortable brace can be designed and fabricated by using ultrasound and computer-aided design and computer-aided manufacturing (CAD/CAM) technology, and be printed directly from a 3D printer with faster production, lower cost, and improved comfort to patients. Also, to investigate the effectiveness of new designed brace. The final outcomes may reduce the total number of spinal surgeries for scoliosis. The benefits not only reduce the health care cost, but also increase the quality of life of these adolescent patients.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Ultrasound; Scoliosis; Orthoses; 3D Printing

Outcome Measures

Primary Outcomes (1)

• Evaluate the in-brace Cobb angle on radiograph

  The in-brace Cobb angle will be measured from the radiograph at the first follow-up clinic.

  It will be completed 2 months after the last participant is recruited.

Secondary Outcomes (1)

• Evaluate participants' compliance on how they use their braces

  The result can be reported within 6 months after the last participant is recruited.

Study Arms (2)

3D Printed Brace

EXPERIMENTAL

This group will receive 3D printed brace

Device: 3D Printed Brace

Traditional Brace

NO INTERVENTION

This group will receive the traditional brace

Interventions

3D Printed Brace DEVICE

All subjects' body shape will be scanned to generate sterolithography (STL) files for 3D printing.

3D Printed Brace

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• It is based on the standard SRS brace studies criteria: a) diagnosed with AIS and new to rigid spinal brace treatment, b) prescribed full-time brace wear (23 hours per day), c) primary Cobb angles 20°- 40°, d) age between 10 -16 years, e) Risser 0-2 (skeletally immature), f) if female either premenarchal or less than 1 year postmenarchal.

You may not qualify if:

• no surgery

Sponsors & Collaborators

• University of Alberta: lead
• Women and Children's Health Research Institute, Canada: collaborator

Study Sites (1)

Stollery Children hospital

Edmonton, Alberta, T6G2B7, Canada

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Edmond Lou, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2017
• First Posted: December 7, 2017
• Study Start: January 15, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)