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

Not Applicable

Completed

• Conditions: Osteogenesis Imperfecta; Adolescent Idiopathic Scoliosis
• Interventions: Device: Scoliosis back brace

• Registration Number: NCT04282408
• Lead Sponsor: IRCCS Eugenio Medea

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-09
• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-21
• Study First Posted: 2020-02-24
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Scoliosis back brace	Group treated with 3D printed brace

Primary Outcome Measures

Name	Time	Method
Comfort and safety evaluation by using surveys	Comparison between traditional and 3D printed brace after 2 weeks of usage of each.	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.

Secondary Outcome Measures

Name	Time	Method
Production process time evaluation	The design and manufacturing will take place in the first 2 weeks between the first and the second visit.	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.
Material amount evaluation	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.	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.
Stability assessment with and without braces measured by sway area	After 2 weeks of treatment with the 3D printed brace.	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.
Gait symmetry metric with and without braces	After 2 weeks of treatment with the 3D printed brace.	Data are collected with an inertial sensor while performing the following task: Timed Up and Go (TUG) test (3 repetitions).

Trial Locations

Locations (1)

IRCCS E. Medea; 🇮🇹 Bosisio Parini, Lecco, Italy