Experimental Evaluation of Back Braces for the Treatment of Spinal Deformity Produced With 3D Printing Technology
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|ClinicalTrials.gov Identifier: NCT04282408|
Recruitment Status : Recruiting
First Posted : February 24, 2020
Last Update Posted : February 26, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Adolescent Idiopathic Scoliosis Osteogenesis Imperfecta||Device: Scoliosis back brace||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Experimental Evaluation of Back Braces for the Treatment of Spinal Deformity Produced With 3D Printing Technology|
|Actual Study Start Date :||July 9, 2019|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||July 31, 2020|
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.
- Comfort and safety evaluation by using surveys [ Time Frame: 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.
- Production process time evaluation [ Time Frame: 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 [ 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. ]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 [ Time Frame: 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 [ Time Frame: 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).
- Thermal distribution on the braces [ Time Frame: After 2 weeks of treatment with the thermoformed and the 3D printed brace. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282408
|Contact: Paolo Fraschini, MD||031877111 ext +firstname.lastname@example.org|
|IRCCS E. Medea||Recruiting|
|Bosisio Parini, Lecco, Italy, 23842|