Actively Recruiting
Constructive Variations of Classic Orthopedic Braces for Spinal Deformity During Growth
Led by Istituto Scientifico Italiano Colonna Vertebrale · Updated on 2024-05-08
470
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The construction methods of the same brace vary on an experiential basis according to who builds them, the prescriber, the characteristics of the patients and also the innovations introduced to ensure greater comfort for the patient. The closure of the brace or the way in which the two shells are fixed varies at the discretion of the orthopedic technician. Plastic materials have also changed. In addition, the use of the classic cast for the production of the negative model was gradually replaced by cad-cam technology. In some cases, modular constructions were introduced with respect to the customized one. All this has changed the classic corsets over time, even without changing their name / type, and according to the hypothesis that their effectiveness remained at least the same, if not even improved. There are no publications that have shown variations in efficacy that can be correlated with some of these stylistic variations. The purpose of this study is to retrospectively investigate whether the various innovations and stylistic variations over time have had an effect on the clinical, functional and radiographic outcomes in growing subjects suffering from spinal deformity treated with corsets at a specialized center.
CONDITIONS
Official Title
Constructive Variations of Classic Orthopedic Braces for Spinal Deformity During Growth
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Idiopathic adolescent scoliosis and/or dorsal hyperkyphosis
- Age under 16 years at the start of observation
- Brace prescription for more than 18 hours per day
- Availability of standing spine radiographs and in-brace radiographs at 1 month or out-of-brace radiographs at 5 �b1 2 months
- Availability of radiographs after growth completion without brace after 48 hours and at 1 year
- Availability of compliance data
- Risser sign between 0 and 4 at first assessment
You will not qualify if you...
- Secondary causes of scoliosis
- History of spinal fusion surgery
- Missing any of the required radiographic examinations per protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
ISICO
Milan, Mi, Italy, 20141
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here