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

NCT ID: NCT04282408

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-09
• Study Completion Date: 2021-05-31

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.

Conditions

Adolescent Idiopathic Scoliosis; Osteogenesis Imperfecta

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Treatment

Group treated with 3D printed brace

Group Type: EXPERIMENTAL

Scoliosis back brace

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

• 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).

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Research Council of Italy - IPCB

UNKNOWN

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

Orthopedic Center "Labsan" (Lecco, Italy)

UNKNOWN

Sponsor Role: collaborator

Politecnico di Milano - DIG Department

UNKNOWN

Sponsor Role: collaborator

IRCCS Eugenio Medea

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS E. Medea

Bosisio Parini, Lecco, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 39871223 (View on PubMed)

Other Identifiers

GIP673

Identifier Type: -

Identifier Source: org_study_id