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Randomized clinical trial of 3D-printed orthosis in the treatment of adolescent idiopathic scoliosis

Randomized clinical trial of 3D-printed orthosis in the treatment of adolescent idiopathic scoliosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027379
Enrollment
Unknown
Registered
2019-11-11
Start date
2020-01-01
Completion date
Unknown
Last updated
2019-11-18

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

Conditions

Adolescent idiopathic scoliosis

Interventions

experimental group:3D-printed orthosis
control group:Boston brace

Sponsors

Peking Universtiy Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to No maximum

Inclusion criteria

Inclusion criteria: a. diagnosis of adolescent idiopathic scoliosis; b. aged >= 10 years; c. Risser class 0-II; d. the Cobb angle of main curve 25°-40°; e. no previous treatment history of AIS; f. before or 12 months after menarche for female.

Exclusion criteria

Exclusion criteria: a. cannot tolerate the brace treatment; b. patients or parents refuse to participate in the study for any reason.

Design outcomes

Primary

MeasureTime frame
compliance;QOL(quality of life);incidence of adverse events;

Secondary

MeasureTime frame
immediate effect of correction;progression of main curve;

Countries

China

Contacts

Public ContactNanfang Xu

Peking University Third Hospital

xunanfang@foxmail.com+86 15652374179

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 17, 2026