Back to resultsExperimental Evaluation of Back Braces for the Treatment of Spinal Deformity Produced With 3D Printing Technology
Primary Purpose
Adolescent Idiopathic Scoliosis, Osteogenesis Imperfecta
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Scoliosis back brace
Sponsored by
About this trial
This is an interventional device feasibility trial for Adolescent Idiopathic Scoliosis focused on measuring scoliosis, spinal deformity
Eligibility Criteria
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).
Sites / Locations
- IRCCS E. Medea
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Group treated with 3D printed brace
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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).
Full Information
NCT ID
NCT04282408
First Posted
February 11, 2020
Last Updated
March 29, 2022
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
1. Study Identification
Unique Protocol Identification Number
NCT04282408
Brief Title
Experimental Evaluation of Back Braces for the Treatment of Spinal Deformity Produced With 3D Printing Technology
Official Title
Experimental Evaluation of Back Braces for the Treatment of Spinal Deformity Produced With 3D Printing Technology
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 9, 2019 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis, Osteogenesis Imperfecta
Keywords
scoliosis, spinal deformity
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Group treated with 3D printed brace
Intervention Type
Device
Intervention Name(s)
Scoliosis back brace
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comfort and safety evaluation by using surveys
Description
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.
Time Frame
Comparison between traditional and 3D printed brace after 2 weeks of usage of each.
Secondary Outcome Measure Information:
Title
Production process time evaluation
Description
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.
Time Frame
The design and manufacturing will take place in the first 2 weeks between the first and the second visit.
Title
Material amount evaluation
Description
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.
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.
Title
Stability assessment with and without braces measured by sway area
Description
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.
Time Frame
After 2 weeks of treatment with the 3D printed brace.
Title
Gait symmetry metric with and without braces
Description
Data are collected with an inertial sensor while performing the following task: Timed Up and Go (TUG) test (3 repetitions).
Time Frame
After 2 weeks of treatment with the 3D printed brace.
Other Pre-specified Outcome Measures:
Title
Thermal distribution on the braces
Description
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.
Time Frame
After 2 weeks of treatment with the thermoformed and the 3D printed brace.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
IRCCS E. Medea
City
Bosisio Parini
State/Province
Lecco
ZIP/Postal Code
23842
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Experimental Evaluation of Back Braces for the Treatment of Spinal Deformity Produced With 3D Printing Technology
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