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| Name | Class |
|---|---|
| National Research Council of Italy - IPCB | UNKNOWN |
| Orthopedic Center "Biomedica Su Misura" (Brescia, Italy) | UNKNOWN |
| Orthopedic Center "Labsan" (Lecco, Italy) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Group treated with 3D printed brace |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scoliosis back brace | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria for Adolescent Idiopathic Scoliosis:
Inclusion Criteria for Osteogenesis Imperfecta:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS E. Medea | Bosisio Parini | Lecco | 23842 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39871223 | Derived | Costantini S, Redaelli DF, Fraschini P, Biffi E, Storm FA. On mobility and gait in scoliosis patients: a comparison of conventional and 3D-printed braces during an instrumented timed-up and go test. BMC Musculoskelet Disord. 2025 Jan 27;26(1):86. doi: 10.1186/s12891-025-08311-w. |
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| ID | Term |
|---|---|
| D010013 | Osteogenesis Imperfecta |
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Politecnico di Milano - DIG Department |
| UNKNOWN |
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| 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. |
| 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. |
| 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. |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |