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

IRCCS Eugenio Medea

Status

Completed

Conditions

Osteogenesis Imperfecta

Adolescent Idiopathic Scoliosis

Treatments

Device: Scoliosis back brace

Study type

Interventional

Funder types

Other

Identifiers

NCT04282408

GIP673

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

3 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Adolescent Idiopathic Scoliosis:

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.

Inclusion Criteria for Osteogenesis Imperfecta:

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).