NCT04282408|Completed
Loading search results
Sponsor study identifier
interventional
10
1 country
1
Study Start
July 9, 2019
Actual (reported)Primary Completion
May 31, 2021
Actual (reported)Study Completion
May 31, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 9, 2019
Actual (reported)February 11, 2020
Actual (reported)February 24, 2020
Actual (reported)May 31, 2021
Actual (reported)May 31, 2021
Actual (reported)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.
Production process time evaluation
The design and manufacturing will take place in the first 2 weeks between the first and the second visit.
Material amount evaluation
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
After 2 weeks of treatment with the 3D printed brace.
Gait symmetry metric with and without braces
After 2 weeks of treatment with the 3D printed brace.
Thermal distribution on the braces
After 2 weeks of treatment with the thermoformed and the 3D printed brace.
Group treated with 3D printed 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
IRCCS E. Medea
Bosisio Parini, Lecco, 23842, Italy
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.
10 participants (actual enrollment reported by the registry).
First Submitted
February 11, 2020
First Posted
February 24, 2020
Study Start
July 9, 2019
Actual (reported)Epigenetic Regulation of Osteogenesis Imperfecta Severity : miROI Study
Adolescent Idiopathic Scoliosis (AIS) Gold Standard for Blood Loss
Contact the study team to confirm eligibility.
Primary Completion
May 31, 2021
Actual (reported)Study Completion
May 31, 2021
Actual (reported)Last Updated
March 31, 2022
Record last verified: 2022-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: