Status:
COMPLETED
Experimental Evaluation of Back Braces for the Treatment of Spinal Deformity Produced With 3D Printing Technology
Lead Sponsor:
IRCCS Eugenio Medea
Collaborating Sponsors:
National Research Council of Italy - IPCB
Orthopedic Center "Biomedica Su Misura" (Brescia, Italy)
Conditions:
Adolescent Idiopathic Scoliosis
Osteogenesis Imperfecta
Eligibility:
All Genders
3-17 years
Phase:
NA
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 t...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
July 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04282408
Start Date
July 9 2019
End Date
May 31 2021
Last Update
March 31 2022
Active Locations (1)
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1
IRCCS E. Medea
Bosisio Parini, Lecco, Italy, 23842