NCT04282408

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 24, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

1.9 years

First QC Date

February 11, 2020

Last Update Submit

March 29, 2022

Conditions

Adolescent Idiopathic ScoliosisOsteogenesis Imperfecta

Keywords

scoliosisspinal deformity

Outcome Measures

Primary Outcomes (1)

  • Comfort and safety evaluation by using surveys

    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.

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

Secondary Outcomes (4)

  • Production process time evaluation

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

  • Material amount evaluation

    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.

  • Stability assessment with and without braces measured by sway area

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

  • Gait symmetry metric with and without braces

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

Other Outcomes (1)

  • Thermal distribution on the braces

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

Study Arms (1)

Treatment

EXPERIMENTAL

Group treated with 3D printed brace

Device: Scoliosis back brace

Interventions

Scoliosis back braceDEVICE

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.

Treatment

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

Location

Related Publications (1)

  • 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.

    PMID: 39871223DERIVED

MeSH Terms

Conditions

Osteogenesis ImperfectaScoliosis

Condition Hierarchy (Ancestors)

OsteochondrodysplasiasBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSpinal CurvaturesSpinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 24, 2020

Study Start

July 9, 2019

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

IT(1)