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

NCT04282408 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-03-31

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • National Research Council of Italy - IPCB

    collaborator UNKNOWN

  • Orthopedic Center "Biomedica Su Misura" (Brescia, Italy)

    collaborator UNKNOWN

  • Orthopedic Center "Labsan" (Lecco, Italy)

    collaborator UNKNOWN

  • Politecnico di Milano - DIG Department

    collaborator UNKNOWN

  • IRCCS Eugenio Medea

    lead OTHER

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-09
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04282408 on ClinicalTrials.gov