NCT04282408

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: IRCCS Eugenio Medea · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adolescent Idiopathic Scoliosis
• Osteogenesis Imperfecta

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-07-09
• Primary completion: 2021-05-31
• Completion: 2021-05-31
• First posted: 2020-02-24
• Last updated: 2022-03-31

Locations

1 site across 1 country: Italy