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

IRCCS Eugenio Medea10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Adolescent Idiopathic Scoliosis Osteogenesis Imperfecta

Interventions

The patients will use the traditional brace, if not already in use, for 2 weeks and then they will wear a 3D printed back brace for the following 2 weeks. Both the braces will be worn for the amount of hours per day prescribed by the physician.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 17 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Comfort and safety evaluation by using surveys

The patients have to fill in ad hoc surveys with open and closed questions about their personal experience with the traditional brace only and after the use of the 3D printed brace. In the closed questions they will have to mark a score from 1 to 7, where higher values correspond to better outcome.

Time frame: Comparison between traditional and 3D printed brace after 2 weeks of usage of each.

Secondary Outcomes

Production process time evaluation

The innovative process will be analysed by recording the time for each phase, from the geometry acquisition with 3D scanning to the delivery of the final 3D printed brace.

Time frame: The design and manufacturing will take place in the first 2 weeks between the first and the second visit.

Material amount evaluation

The production process will be also analyzed in term of amount of material used: both for the final product and for the part wasted in building supports.

Time frame: The meaasurements will take place immediately after the brace is removed from the printer and right before delivering the brace to the patient in its final layout.

Stability assessment with and without braces measured by sway area

Data are collected with an inertial sensor while performing the following task: maintaining a static standing position for 1 minute (3 repetitions), both with and without the braces.

Time frame: After 2 weeks of treatment with the 3D printed brace.

Gait symmetry metric with and without braces

Data are collected with an inertial sensor while performing the following task: Timed Up and Go (TUG) test (3 repetitions).