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

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 Overview

• Status: Completed
• Conditions: Osteogenesis Imperfecta; Adolescent Idiopathic Scoliosis
• Intervention / Treatment: Device: Scoliosis back brace

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lecco
    • Bosisio Parini, Lecco, Italy, 23842
      • IRCCS E. Medea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Group treated with 3D printed brace	Device: Scoliosis back brace; 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.

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thermal distribution on the braces	The subjects will be acquired with both the braces (thermoformed and 3D printed) and without using a thermal camera in order to evaluate the temperature distribution and analyse the differences among the different conditions.	After 2 weeks of treatment with the thermoformed and the 3D printed brace.

Collaborators and Investigators

• Sponsor: IRCCS Eugenio Medea
• Collaborators: National Research Council of Italy - IPCB; Orthopedic Center "Biomedica Su Misura" (Brescia, Italy); Orthopedic Center "Labsan" (Lecco, Italy); Politecnico di Milano - DIG Department

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2019
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (Actual): February 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: scoliosis; spinal deformity
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Musculoskeletal Diseases; Connective Tissue Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Bone Diseases, Developmental; Osteochondrodysplasias; Collagen Diseases; Congenital Abnormalities; Scoliosis; Osteogenesis Imperfecta
• Other Study ID Numbers: GIP673

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No