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

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04282408
• Other study ID #: GIP673
• Status: Completed
• Phase: N/A
• Start date: July 9, 2019
• Est. completion date: May 31, 2021

Study information

• Verified date: March 2022
• Source: IRCCS Eugenio Medea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Congenital Abnormalities
• Osteogenesis Imperfecta
• Scoliosis

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS E. Medea	Bosisio Parini	Lecco

Sponsors (5)

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

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.