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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04282408
Recruitment Status : Recruiting
First Posted : February 24, 2020
Last Update Posted : February 26, 2020
Sponsor:
Collaborators:
National Research Council of Italy - IPCB
Orthopedic Center "Biomedica Su Misura" (Brescia, Italy)
Orthopedic Center "Labsan" (Lecco, Italy)
Politecnico di Milano - DIG Department
Information provided by (Responsible Party):
IRCCS Eugenio Medea

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.


Condition or disease Intervention/treatment Phase
Adolescent Idiopathic Scoliosis Osteogenesis Imperfecta Device: Scoliosis back brace Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Experimental Evaluation of Back Braces for the Treatment of Spinal Deformity Produced With 3D Printing Technology
Actual Study Start Date : July 9, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020


Arm Intervention/treatment
Experimental: Treatment
Group treated with 3D printed brace
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282408


Contacts
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Contact: Paolo Fraschini, MD 031877111 ext +39 paolo.fraschini@lanostrafamiglia.it

Locations
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Italy
IRCCS E. Medea Recruiting
Bosisio Parini, Lecco, Italy, 23842
Sponsors and Collaborators
IRCCS Eugenio Medea
National Research Council of Italy - IPCB
Orthopedic Center "Biomedica Su Misura" (Brescia, Italy)
Orthopedic Center "Labsan" (Lecco, Italy)
Politecnico di Milano - DIG Department
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Responsible Party: IRCCS Eugenio Medea
ClinicalTrials.gov Identifier: NCT04282408    
Other Study ID Numbers: GIP673
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IRCCS Eugenio Medea:
scoliosis
spinal deformity
Additional relevant MeSH terms:
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Scoliosis
Osteogenesis Imperfecta
Congenital Abnormalities
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Osteochondrodysplasias
Bone Diseases, Developmental
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases