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Experimental Evaluation of Back Braces for the Treatment of Spinal Deformity Produced With 3D Printing Technology | Clinical Trials | Clareo Health

COMPLETEDNA

Experimental Evaluation of Back Braces for the Treatment of Spinal Deformity Produced With 3D Printing Technology

NCT04282408•IRCCS Eugenio Medea

View on ClinicalTrials.gov

Summary

The proposed investigation is a pilot study that involves pediatric patients affected by spinal deformity (Adolescent Idiopathic Scoliosis and Osteogenesis Imperfecta). The main goal is to evaluate the acceptability, the safety and the overall satisfaction of the patients wearing the back braces produced with an innovative methodology using 3D printers, compared to the current braces manufactured with a production model based on thermoforming, that has well-established clinical efficacy.

Eligibility

Age

3 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•ages 6 to 17 years;
•lumbar or thoracolumbar scoliosis;
•measured rib hump greater than 5 degrees with scoliometer;
•Cobb angle, measured on frontal X-ray images, within 15 and 30 degrees.
•ages 3 to 17 years;
•vertebral pain and/or vertebral deformity with typical double-concave lenses shape and/or deformity in frontal or sagittal planes assessed with clinical traction, deflection or derotational tests.

Exclusion Criteria

•skin allergies;
•behavioural and psychiatric problems (e.g., emotional problems, anxiety, panic);
•chest dimensions beyond printing limits (i.e., maximum diameter 35 cm and maximum height 60 cm).

Locations (1)

IRCCS E. Medea

Bosisio Parini, Lecco, Italy

Key Dates

Start Date

July 9, 2019

Primary Completion Date

May 31, 2021

Completion Date

May 31, 2021

Last Updated

March 31, 2022

Enrollment

ACTUAL participants

Conditions

Adolescent Idiopathic ScoliosisOsteogenesis Imperfecta

Interventions

Scoliosis back brace

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RECRUITINGNA

3D, Dynamic and Mechanically-informed Decision Making in AIS

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RECRUITINGNA

Personalized Prevention and Treatment Strategies for Adolescent Idiopathic Scoliosis Via a Comprehensive Health Management Platform

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 31, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Experimental Evaluation of Back Braces for the Treatment of Spinal Deformity Produced With 3D Printing Technology

Inclusion Criteria

Exclusion Criteria

Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis

3D, Dynamic and Mechanically-informed Decision Making in AIS

Personalized Prevention and Treatment Strategies for Adolescent Idiopathic Scoliosis Via a Comprehensive Health Management Platform

Effects of Bisphosphonates on OI-Related Hearing Loss

Kids With Iron Deficiency and Scoliosis

Effect of Scapular Stabilization Exercises in Individuals With Adolescent Idiopathic Scoliosis