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Efficacy of 3D-printed braces in patients with AIS: a preferred non-inferiority randomized controlled trial

Efficacy of 3D-printed braces in patients with AIS: a preferred non-inferiority randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100522
Enrollment
Unknown
Registered
2025-04-10
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adolescent idiopathic scoliosis

Interventions

3D Printed Group:3D scanning was used to obtain three-dimensional data of the patients spine, the brace model was designed by reverse engineering software, and the personalized brace was 3D printed us
CAD/CAM Group:The brace was fabricated based on traditional CAD/CAM technology, and the material was consistent with the 3D printed group. The brace was worn for >=20 hours per day, and the brace was

Sponsors

Guangzhou Sport University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for scoliosis established by the Scoliosis Research Society (SRS): a full-length orthopantomogram of the spine in the standing position showing the presence of scoliosis without structural deformity; 2. Age 10-18 years; 3. Cobb's angle 20°-50°; 4. Risser's sign <= 3; 5. First time receiving brace treatment; 6. Good compliance, able to cooperate in completing follow-up visits, complete clinical data, and signed informed consent.

Exclusion criteria

Exclusion criteria: 1 Non-idiopathic scoliosis (e.g., congenital, neuromuscular); 2. Previous spinal surgery or conservative treatment (e.g., physical therapy, orthotics); 3. Presence of growth and developmental disorders, combined neurologic, musculoskeletal, skeletal, infectious, and psychiatric medical history; 4. Allergy to brace materials (e.g., polylactic acid, polyethylene); 5. Expected inability to complete >=80% of the follow-up program.

Design outcomes

Primary

MeasureTime frame
Cobb angle;

Secondary

MeasureTime frame
Brace compliance;SRS-22 scale;Adverse reaction;

Countries

China

Contacts

Public ContactZhang Xiaohui

Guangzhou Sport University

Sportsmedzxh@sina.com+86 135 8035 8299

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026