Clinical trial NCT04282408: 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
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Osteogenesis Imperfecta
Keywords: scoliosis
spinal deformity
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
Collaborators: name: National Research Council of Italy - IPCB
name: Orthopedic Center "Biomedica Su Misura" (Brescia, Italy)
name: Orthopedic Center "Labsan" (Lecco, Italy)
name: Politecnico di Milano - DIG Department
First posted: 2020-02-24
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


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).

Primary outcomes:
measure: Comfort and safety evaluation by using surveys
timeFrame: Comparison between traditional and 3D printed brace after 2 weeks of usage of each.
Secondary outcomes:
measure: Production process time evaluation
timeFrame: The design and manufacturing will take place in the first 2 weeks between the first and the second visit.
measure: Material amount evaluation
timeFrame: 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.
measure: Stability assessment with and without braces measured by sway area
timeFrame: After 2 weeks of treatment with the 3D printed brace.
measure: Gait symmetry metric with and without braces
timeFrame: After 2 weeks of treatment with the 3D printed brace.
Other outcomes:
measure: Thermal distribution on the braces
timeFrame: After 2 weeks of treatment with the thermoformed and the 3D printed brace.
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS E. Medea
state: Lecco
Study officials:
References: