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

Study Overview
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Brief Summary
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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.

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

Conditions
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Adolescent Idiopathic Scoliosis, Osteogenesis Imperfecta

Intervention / Treatment
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* Device: Scoliosis back brace


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Group treated with 3D printed brace | Device: Scoliosis back brace<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Comparison between traditional and 3D printed brace after 2 weeks of usage of each. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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). | After 2 weeks of treatment with the 3D printed brace. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scoliosis, spinal deformity