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NCT Number: NCT04282408

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

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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Key information

Conditions

Adolescent Idiopathic Scoliosis Bone Diseases Bone Diseases, Developmental Collagen Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Genetic Diseases, Inborn Musculoskeletal Diseases Osteochondrodysplasias Osteogenesis Imperfecta Scoliosis Skin and Connective Tissue Diseases Spinal Curvatures Spinal Diseases

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Adolescent Idiopathic Scoliosis:

  • 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.

Inclusion criteria

for Osteogenesis Imperfecta:

  • 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).

Treatment and study plan

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.

Primary outcomes

  1. Comfort and safety evaluation by using surveys

    Time frame: Comparison between traditional and 3D printed brace after 2 weeks of usage of each.

    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.

Secondary outcomes

  1. Production process time evaluation

    Time frame: The design and manufacturing will take place in the first 2 weeks between the first and the second visit.

    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.

  2. Material amount evaluation

    Time frame: 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.

    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.

  3. Stability assessment with and without braces measured by sway area

    Time frame: After 2 weeks of treatment with the 3D printed brace.

    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.

  4. Gait symmetry metric with and without braces

    Time frame: After 2 weeks of treatment with the 3D printed brace.

    Data are collected with an inertial sensor while performing the following task: Timed Up and Go (TUG) test (3 repetitions).

Other outcomes

  1. Thermal distribution on the braces

    Time frame: After 2 weeks of treatment with the thermoformed and the 3D printed brace.

    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.

Sponsors and collaborators

Lead sponsor

IRCCS Eugenio Medea

Other

Collaborators

  • National Research Council of Italy - IPCB
  • Orthopedic Center "Biomedica Su Misura" (Brescia, Italy)
  • Orthopedic Center "Labsan" (Lecco, Italy)
  • Politecnico di Milano - DIG Department

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 24, 2020
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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